April 17, 2024—Roche announced that its Elecsys pTau217 assay received breakthrough device designation from the FDA.
Read More »Author Archives: CAP TODAY
Newcomer Supply to distribute HistoCyte cell line controls
April 16, 2024—Newcomer Supply announced it is distributing HistoCyte Laboratories cell line controls.
Read More »Roche CDx to ID patients eligible for Enhertu gets CE mark
April 15, 2024—Roche announced it obtained the CE mark for its Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (trastuzumab deruxtecan) may be considered as a targeted treatment.
Read More »FDA clears Pathfast POC hs-cTnI test
April 12, 2024—Polymedco announced FDA 510(k) clearance of the Pathfast hs-cTnI-II, a high-sensitivity cardiac troponin assay for the diagnosis of myocardial infarction at the point of care.
Read More »BYG4lab opens U.S. subsidiary in Chicago
April 12, 2024—BYG4lab Group has opened its U.S subsidiary, BYG4lab, in Chicago and appointed Tim Bickley, MLS(ASCP), MBA, CPHIMS, vice president of sales for the U.S. market.
Read More »Bio-Rad expands availability of Unity Next Peer QC
April 11, 2024—Bio-Rad Laboratories has launched its Unity Next Peer QC data management software in Europe, the Middle East, and Africa.
Read More »Bosch, Randox invest €150 million in Vivalytic platform
April 10, 2024—Bosch and Randox Laboratories have entered into a strategic partnership in which the two companies will invest around €150 million in joint research, development, and distribution for new tests for Bosch’s Vivalytic platform.
Read More »Streck launches Protein Plus BCT whole blood collection tube
April 8, 2024—Streck announced the launch of its Protein Plus BCT direct draw whole blood collection tube to provide sample integrity during storage, shipping, and handling of blood samples.
Read More »Sysmex now selling hemostasis products under its brand
April 5, 2024—Sysmex America announced its plan to sell hemostasis instruments and reagents to laboratories in the United States beginning this month, under the company’s mutual original equipment manufacturer agreement with Siemens Healthineers.
Read More »Risant Health completes acquisition of Geisinger
April 4, 2024—Risant Health has completed its acquisition of Geisinger, the first health system to join Risant in expanding access to value-based care in communities across the country.
Read More »Abbott TBI cartridge cleared for use with whole blood
April 3, 2024—Abbott's i-Stat TBI cartridge has received FDA clearance for use with whole blood, allowing clinicians to help assess patients with suspected concussion at the patient's bedside.
Read More »SpotFire R/ST panel gets 510(k) clearance, CLIA waiver
April 2, 2024—BioMérieux has received FDA 510(k) clearance and CLIA waiver approval for the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel.
Read More »FDA approves test to screen for malaria in blood donors
April 1, 2024—Roche announced FDA approval of the Cobas Malaria test, a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium RNA and DNA in whole blood samples from individual human donors.
Read More »Next-gen StatStrip glucose system gets 510(k) clearance
March 29, 2024—Nova Biomedical announced the U.S. launch of its 510(k)-cleared, next-generation StatStrip Glucose Hospital meter system.
Read More »StatLab acquires Poly Scientific R&D
March 28, 2024—StatLab Medical Products announced the acquisition of Poly Scientific R&D, a manufacturer and supplier of pathology stains, reagents, and paraffin for anatomic pathology laboratories.
Read More »Labcorp acquires assets of BioReference lab testing business
March 28, 2024—Labcorp and Opko Health announced they have entered into an agreement for Labcorp to acquire select assets of BioReference Health, a wholly owned subsidiary of Opko, for $237.5 million.
Read More »De novo classification granted for plasma cell enrichment kit
March 27, 2024—Stemcell Technologies announced that the FDA has granted de novo classification for its immunomagnetic plasma cell enrichment kit.
Read More »Gestalt demos new PathFlow features at USCAP meeting
March 26, 2024—Gestalt Diagnostics announce the launch of its AI Algorithm Evaluator, a new tool within the company’s PathFlow digital pathology platform.
Read More »Bayer, Thermo Fisher to develop NGS CDx assays
March 21, 2024—Bayer and Thermo Fisher Scientific announced that they will develop next-generation sequencing–based companion diagnostic assays to help identify patients who may benefit from Bayer’s precision cancer therapies.
Read More »Roche debuts Navify solutions at HIMSS24
March 15, 2024—Roche debuted its Navify Analytics for POC and Navify Monitoring solutions at the Healthcare Information and Management Systems Society global health conference in Orlando, March 11–15.
Read More »Sekisui gets EUA for Osom flu, SARS-CoV-2 test
March 13, 2024—Sekisui Diagnostics received EUA clearance for its Osom Flu SARS-CoV-2 Combo test for use in professional and home testing settings.
Read More »New ASCCP guidelines now include dual-stain triage testing
March 12, 2024—Roche Diagnostics announced the release of new guidelines from the American Society for Colposcopy and Cervical Pathology and other members of the Enduring Consensus Cervical Cancer Screening and Management Guidelines committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus infection is transforming into cervical precancer.
Read More »Pramana joins Proscia Ready
March 11, 2024—Proscia announced that Pramana, an artificial intelligence–enabled health technology company, is now a Proscia Ready partner.
Read More »FDA clears Diasorin Liaison Plex system
March 5, 2024—Diasorin announced FDA 510(k) clearance for its Liaison Plex platform and Flex respiratory assay.
Read More »Sebia gets FDA clearance for free light chain assays
Sebia announced it has received FDA 510(k) clearance for its free light chain kappa and lambda assays, intended to aid in diagnosing and monitoring patients who have multiple myeloma or immunoglobulin light chain amyloidosis.
Read More »Bruker to acquire EliTechGroup
March 1, 2024—Bruker Corp. has entered into a definitive share purchase agreement to acquire EliTechGroup for €870 million (about $940 million) in cash, excluding EliTech’s clinical chemistry business.
Read More »Binx enters into distribution agreement with Cardinal Health
Feb. 21 2024—Binx Health announced a national distribution agreement with Cardinal Health to expand access to care with its CLIA-waived, FDA-cleared Binx IO.
Read More »Roche, PathAI to develop AI digital pathology algorithms
Feb. 14, 2024—Roche announced it has entered into an agreement with PathAI to develop AI-enabled digital pathology algorithms for Roche Tissue Diagnostics’ companion diagnostics business.
Read More »Bio-Rad publishes third workbook in QC series
Feb. 13, 2024—Bio-Rad Laboratories has published its third workbook in a series that offers Professional Acknowledgement for Continuing Education credits.
Read More »Proscia gets FDA 510(k) clearance for Concentriq AP-Dx
Feb. 12, 2024—Proscia has received FDA 510(k) clearance for its Concentriq AP-Dx diagnostic software for primary diagnosis.
Read More »Health Canada approves Corista DP3 platform
Feb. 7, 2024—Corista announced it has received a class II medical device license from Health Canada for its DP3 platform, a web-based image-management system for digital pathology.
Read More »CellaVision, Sysmex sign strategic alliance agreement
Feb. 6, 2024—CellaVision and Sysmex announced a strategic alliance agreement that expands their mutual commitment until 2038.
Read More »Beckman Coulter unveils DxC 500 AU chemistry analyzer
Feb. 5, 2024—Beckman Coulter Diagnostics unveiled its DxC 500 AU chemistry analyzer today at Medlab Middle East in Dubai.
Read More »FDA clears Hologic Genius digital cytology system
Feb. 2, 2024—Hologic announced that its Genius Digital Diagnostics system with the Genius Cervical AI algorithm has received clearance from the FDA, making it the first FDA-cleared digital cytology system that combines deep-learning–based artificial intelligence with advanced volumetric imaging technology to help identify precancerous lesions and cervical cancer cells.
Read More »iSpecimen, TriMetis partner to enhance tissue-based research
Jan. 24, 2024—The company iSpecimen, an online marketplace that connects life science researchers seeking human biospecimens for medical research with health care organizations that have such specimens, announced it has entered into a pilot program agreement with TriMetis Life Sciences.
Read More »Cepheid gets CLIA waiver for Xpert Xpress MVP
Jan. 19, 2024—Cepheid announced it has received FDA clearance with a CLIA waiver for the Xpert Xpress MVP, a multiplex vaginal panel that can now be performed in near-patient settings.
Read More »BioMérieux acquires software company Lumed
Jan. 11, 2024—BioMérieux has acquired the entire share capital of software company Lumed, increasing its stake from 16 to 100 percent.
Read More »Horiba Medical launches next-gen HELO hematology solution
Jan. 9, 2024—Horiba Medical has launched the CE-IVDR-approved HELO 2.0 high-throughput automated hematology platform.
Read More »New chapter in digital pathology
Jan. 8, 2024—Advancements in whole slide imaging, integration of AI, and global collaboration networks are three areas the new president of the Digital Pathology Association highlighted in his first communication with DPA members this year.
Read More »Sekisui, Aptitude partner to provide POC COVID test
Jan. 4, 2024—Sekisui Diagnostics formalized an exclusive distribution agreement with Aptitude Medical Systems to sell the Aptitude Metrix COVID-19 test in the United States.
Read More »FormaPath, UB CAT announce clinical R&D collaboration
Jan. 4, 2024—FormaPath and the University at Buffalo Center for Advanced Technology in Big Data and Health Sciences (UB CAT) announced their collaboration to further test and develop FormaPath’s AdiPress, an automated lymph node dissection device. FormaPath and John Tomaszewski, MD, SUNY distinguished professor and the Peter A. Nickerson, PhD, Professor and Chair, Department of Pathology and Anatomical Sciences, Jacobs ...
Read More »Roche to acquire LumiraDx’s POC technology
Jan. 2, 2024—Roche announced it has entered into a definitive agreement to acquire LumiraDx’s point-of-care technology platform business, which offers a range of immunoassay and clinical chemistry tests that can be stored at room temperature.
Read More »Tosoh G8 now connects to Sysmex XN-9000, XN-9100 systems
Dec. 27, 2023—Tosoh Bioscience has entered into an agreement with Sysmex America in which its HLC-723G8 automated glycohemoglobin analyzers can now be connected to Sysmex XN-9000 and XN-9100 automated hematology systems in the United States, Latin America, and Canada.
Read More »FDA clears QuidelOrtho Savanna platform, HSV 1+2/VZV assay
Dec. 21, 2023—QuidelOrtho has received FDA 510(k) clearance for its Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of herpes simplex virus types 1 and 2 and varicella zoster virus nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens from symptomatic patients.
Read More »Corista DP3 platform gets CE IVD mark
Dec. 14, 2023—Corista announced today that its DP3 platform has been certified with the CE in vitro diagnostic mark for routine diagnosis in the European Union and United Kingdom.
Read More »CLSI releases breakpoint implementation toolkit
Dec. 12, 2023—The Clinical and Laboratory Standards Institute, Association of Public Health Laboratories, American Society for Microbiology, the CAP, and Centers for Disease Control and Prevention have jointly developed a breakpoint implementation toolkit (BIT) to assist clinical laboratories in updating minimal inhibitory concentration breakpoints.
Read More »Smart In Media launches grossing camera and software
Dec. 7, 2023—Smart In Media announced the release of its PathoZoom LiveView Macro camera and PathoZoom software.
Read More »CellNetix selects Proscia for digital pathology
Dec. 6, 2023—CellNetix Pathology and Laboratories and Proscia announced today that CellNetix has selected Proscia to digitize a portion of its volume of 1 million glass slides scanned per year.
Read More »Spire partners with Tribun to advance pathology services
Dec. 5, 2023—Spire Healthcare, through its partnership with the Paris-based digital pathology company Tribun Health, announced its plans to launch its new digital infrastructure and services early this month.
Read More »FormaPath launches AdiPress for lymph node dissection
Nov. 29, 2023—FormaPath announced the commercial launch of AdiPress, an automated tool to standardize lymph node dissection.
Read More »Paige, Nuance to create largest pathology consult network
Nov. 27, 2023—Paige announced it has teamed up with Nuance, a Microsoft company, to create the largest digital consultation network in pathology. By merging Paige’s digital pathology tools, such as FullFocus and FullFolio, with PowerShare, Nuance’s nationwide image sharing network, laboratories with digital capability can gain access to hospitals and health care systems for consultations. “Our collaboration with Nuance heralds ...
Read More »EntroGen gets PMA for CRCdx RAS mutation detection kit
Nov. 21, 2023—The FDA has granted approval for EntroGen’s CRCdx RAS mutation detection kit as a companion diagnostic for Vectibix (panitumumab).
Read More »LGC launches unmethylated and methylated ctDNA mixes
Nov. 16, 2023—LGC Clinical Diagnostics has launched Seraseq unmethylated and methylated ctDNA mutation mixes for assay development, validation, and routine performance monitoring.
Read More »Amplify the value of your AP LIS
Now available from NovoPath and PathAI is a free webinar that aims to help viewers understand how digital pathology and AI can help an organization. Speakers Eric Walk, MD, Jim Sweeney, and R. Shawn Kinsey, MD, from PathAI and Ed Youssef from NovoPath discuss how digital pathology and AI can streamline your pathology workflows and how some of the largest labs in the United States are already applying these applications. The webinar, titled “Digital pathology and artificial intelligence 101: unlocking value from the AP LIS,” is available through the link here. Registration is required to access the webinar.
Read More »Leica adds software features to Aperio GT 450 scanner
Nov. 13, 2023—Leica Biosystems has released three software features that aim to improve image quality and flexible scanning solutions in research settings for its Aperio GT 450 digital pathology scanner.
Read More »Elecsys NfL test granted FDA breakthrough device designation
Nov. 10, 2023—Roche announced that its Elecsys neurofilament light chain test for multiple sclerosis received breakthrough device designation from the FDA.
Read More »Paige Lymph Node gets FDA breakthrough device designation
Nov. 7, 2023—Paige announced that the FDA has granted breakthrough device designation for Paige Lymph Node, an AI application used to detect breast cancer metastases in lymph node tissue.
Read More »Roche gets FDA approval for HPV test on Cobas 5800 system
Nov. 6, 2023—Roche announced that the FDA has approved the Cobas HPV test for use on its next-generation Cobas 5800 molecular instrument.
Read More »FDA approves Abbott HPV test to run on Alinity m
Nov. 3, 2023—Abbott has received FDA approval for its molecular human papillomavirus screening test to run on its Alinity m system.
Read More »Bio-Rad cardiac control compatible with Beckman analyzers
Nov. 2, 2023—Bio-Rad Laboratories has announced the expanded compatibility of its cardiac control, Cardiac Advance, to include Beckman Coulter instruments.
Read More »Roche launches vertical transportation for patient lab samples
Oct. 18, 2023—Roche announced the U.S. launch of its Cobas Connection Modules Vertical, designed to help low-, mid-, and high-volume laboratories optimize space, productivity, and patient care. The CCM Vertical includes elevator units, overhead conveyors, and overhead turn units that integrate with Roche’s other CCM solutions. It transports patient samples up, down, and across and between rooms; around doorways, emergency ...
Read More »BioMérieux announces CE mark for Vidas TBI test
Oct. 17, 2023—BioMérieux announced it has received the CE mark for its Vidas TBI (GFAP, UCH-L1), a test to support the assessment of patients who have mild traumatic brain injury. The blood test measures the concentration of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1), two brain biomarkers that are released into the bloodstream during the first hour ...
Read More »OGT, Intelliseq partner to provide NGS analysis and reporting
Oct. 12, 2023—OGT announced a partnership with Intelliseq, a genome informatics company and provider of next-generation sequencing analysis solutions.
Read More »Bio SB launches TintoStainer Plus automatic IHC stainer
Oct. 9, 2023—Bio SB has launched a fully automated immunohistochemistry platform for deparaffinization and antigen retrieval and staining.
Read More »mTuitive introduces Insight database
Oct. 6, 2023—MTuitive has introduced its mTuitive Insight, a consolidated database designed to give a comprehensive view of cancer data and tie together structured data from any health care IT system.
Read More »FDA clears Nova Prime Plus for microcapillary sample mode
Oct. 5, 2023—Nova Biomedical announced that the FDA has granted 510(k) clearance for a microcapillary sample mode on the company’s Stat Profile Prime Plus critical care blood gas analyzer. It is available as a standard feature.
Read More »FDA clears Thermo Fisher chromogranin A assay
Sept. 28, 2023—Thermo Fisher Scientific announced FDA clearance of its Thermo Scientific Brahms CgA II Kryptor, an automated immunofluorescent assay for the quantitative determination of the concentration of chromogranin A in human serum.
Read More »Pillar Biosciences launches OncoReveal Core LBx NGS kit
Sept. 27, 2023—Pillar Biosciences announced the global launch of OncoReveal Core LBx, a research use only, liquid biopsy–based next-generation sequencing kit for pan-cancer tumor profiling.
Read More »FDA clears Streck quality controls for bloodstream infections
Sept. 26, 2023—Streck announced that its MDx-Chex for BC-GP and MDx-Chex for BC-GN quality controls, designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive (BC-GP) and Gram-Negative (BC-GN) tests for blood stream infection and sepsis, have been granted FDA clearance for use in diagnostic procedures.
Read More »BioMérieux submits 510(k), CLIA-waiver application for R/ST panel
Sept. 25, 2023—BioMérieux has submitted the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel to the FDA for a dual 510(k) clearance and CLIA waiver.
Read More »QuidelOrtho gets CLIA waiver for Sofia 2 SARS Antigen+ FIA
Sept. 22, 2023—QuidelOrtho has been granted a CLIA waiver from the FDA for its Sofia 2 SARS Antigen+ FIA.
Read More »Evident announces alliance to automate digital pathology workflows
Sept. 19, 2023—Evident announced an alliance with Corista, Sakura Finetek, and Visiopharm to deliver an automated, end-to-end workflow solution for pathology in the United States.
Read More »Pathology Visions 2023
“Igniting Digital Pathology Transformation”—the theme for Pathology Visions 2023. The Digital Pathology Association (DPA) invites you to attend this year’s annual meeting taking place October 29–31 in Orlando, Fla. Pathology Visions brings together hundreds of pioneers and peers across the field of digital pathology to address real-world, practical applications of digital pathology and AI today, as well as the future. Attendees have access to more than 50 expert presenters, over 70 poster presentations, nearly 50 vendors showcasing the latest innovations, countless opportunities for discussion and engagement, and much more. If you are a clinician, scientist, technician, or trainee #PathVisions23 is the place for you.
Read More »Primera unveils Signature EVO slide and cassette printers
Sept. 12, 2023—Primera Technology has launched its next-generation Signature EVO slide printer and Signature EVO cassette printer.
Read More »Tribun Health secures €15 Million in series B funding
Sept. 6, 2023—Paris-based Tribun Health announced the completion of its series B funding, securing an investment of €15 million.
Read More »MMQCI releases BCR-ABL linearity panel
Aug. 28, 2023—Maine Molecular Quality Controls released the Xpert BCR-ABL IS p210 Linearity Panel C207, intended for use as an assayed external quality control to monitor the performance of the in vitro quantitative detection of BCR-ABL1 translocation mRNA e14a2/b3a2 transcripts and the ABL1 endogenous control mRNA transcript.
Read More »Evident introduces Slideview DX VS-M1R digital scanner
Aug. 25, 2023—Evident has introduced its Slideview DX VS-M1R whole slide imaging system, for research use only.
Read More »FDA clears PixCell HemoScreen for direct capillary sampling
Aug. 24, 2023—PixCell Medical announced that the FDA has granted 510(k) clearance for direct capillary sampling with the HemoScreen 5-part differential CBC analyzer.
Read More »Sophia Genetics expands relationship with Gustave Roussy
Aug. 23, 2023—Sophia Genetics announced the expansion of its relationship with Gustave Roussy in which the cancer center will use the Sophia DDM digital analytics platform for all relevant samples, including those related to solid tumors and hematologic and hereditary cancers.
Read More »Rhodes Group releases white paper on risk adjustment strategy
Rhodes Group, a wholly owned subsidiary of TriCore, has published a white paper on the value of using laboratory results within a risk adjustment identification strategy. By using TriCore’s laboratory data, Rhodes Group says it was able to render a potential $3.7 million for a payer’s 7,000 members. Access the white paper, “Using Lab Results Within a Risk Adjustment Strategy Is Valuable for Understanding the Conditions Within a Population of Members,” here: https://www.rhodesgroup.com/publications
Read More »Pathology Visions 2023
Aug. 17, 2023—The Digital Pathology Association annual meeting, Pathology Visions 2023, will take place Oct. 29–31 in Orlando, Fla.
Read More »FDA clears Abbott Alinity h-series hematology system
Aug. 16, 2023—Abbott has received FDA clearance for its Alinity h-series hematology system, which includes the Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer.
Read More »FDA approves Qiagen CDx for gastrointestinal stromal tumors
Aug. 9, 2023—Qiagen announced FDA approval of its Therascreen PDGFRA RGQ PCR kit, a companion diagnostic intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors (GIST) who may be eligible for treatment with avapritinib (Ayvakit, Blueprint Medicines).
Read More »Mainz advanced adenoma biomarkers feasibility study results
Aug. 7, 2023—Mainz Biomed announced results of an independent feasibility study conducted in collaboration with members of the National Cancer Institute’s Early Detection Research Network to evaluate the company’s portfolio of five mRNA biomarkers, which it acquired from Université de Sherbrooke, Quebec.
Read More »HemoSonics Quantra awarded Innovative Technology contract
Aug. 4, 2023—HemoSonics announced that its Quantra hemostasis system has received an Innovative Technology contract award from Vizient, whose members include more than half of all acute care hospitals in the United States.
Read More »Hc1 partners with AON to develop Workforce Optimization
Aug. 2, 2023—Hc1 announced a development partnership with American Oncology Network.
Read More »FDA clears respiratory viral panel for BD Max
Aug. 1, 2023—BD announced FDA 510(k) clearance of its BD Respiratory Viral Panel for the BD Max system.
Read More »Werfen completes acquisition of Immucor
July 27, 2023—Werfen announced it has completed its acquisition of Immucor after obtaining all necessary regulatory and antitrust approvals.
Read More »Illumina, Pillar Biosciences announce partnership
July 25, 2023—Illumina and Pillar Biosciences announced a strategic partnership to make Pillar’s suite of oncology assays commercially available worldwide as part of Illumina’s portfolio of oncology products.
Read More »HNL selects Proscia, Leica for digital pathology
July 24, 2023—HNL Lab Medicine announced it has selected solutions from Proscia and Leica Biosystems to establish an advanced digital pathology practice.
Read More »FDA clears Siemens Atellica CI analyzer
July 20, 2023—Siemens Healthineers announced that its Atellica CI analyzer for immunoassay and clinical chemistry testing has received FDA clearance and is now available in many countries.
Read More »Siemens ELF test gets FDA breakthrough device designation
July 18, 2023—The FDA has granted a breakthrough device designation for Siemens Healthineers Enhanced Liver Fibrosis Test, the only blood test granted FDA marketing authorization for prognostication of disease progression in patients with advanced fibrosis due to non-alcoholic fatty liver disease.
Read More »FDA clears Roche tTau/Abeta42 Alzheimer’s assays
June 28, 2023—Roche announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays have received FDA 510(k) clearance and will be available in Q4 2023.
Read More »Danish National Genome Center selects Qiagen’s QCI Interpret
June 26, 2023—Qiagen announced that its variant interpretation and reporting software, Qiagen Clinical Insight (QCI) Interpret, was chosen by the Danish National Genome Center to provide interpretation of oncology results generated from whole genome sequencing data.
Read More »Randox acquires Cellix
June 23, 2023—Randox (Crumlin, U.K.) has acquired Cellix, a Dublin-based company that develops microfluidic tools and impedance flow cytometers for cell analysis.
Read More »Dark Daily to present free webinar on
Z-Code application process
UnitedHealthcare is requiring, effective Aug. 1, that genetic test claims associated with about 250 CPT codes include a Z-Code issued by the MolDx Diagnostic Exchange (DEX) registry, operated by Palmetto GBA, a Medicare administrative contractor. To help clinical labs meet their needs for swift Z-Code registration of their genetic tests, the Dark Report and Dark Daily are presenting a free, 90-minute webinar titled “Essential Guide to Obtaining Z-Codes for Molecular and Genetic Tests” on Thursday, June 29, at 1 pm EDT. The keynote speaker is Gabriel Bien-Willner, MD, PhD, chief medical officer of Palmetto GBA and medical director of the Molecular Diagnostic Services Program (MolDx). He will provide an up-to-the-minute picture of the DEX MolDx Z-Code registry, including the application and documentation processes needed to register a molecular test and obtain a unique Z-Code for that test.
Read More »FDA clears Stago Max Generation 3 analyzers
June 21, 2023—Diagnostica Stago announced FDA 510(k) clearance of its Max Generation 3 analyzers, the STA R Max 3 and STA Compact Max 3. The analyzers feature a mechanical viscosity-based detection system and a preanalytical module that aims to ensure quality results with fewer interventions and flags, and efficient, automated sample management. The new expert preanalytical check controls fill volumes ...
Read More »Study shows clinical value of QFT-Plus with CD8 technology
June 19, 2023—Qiagen announced the publication of a study that aimed to compare and analyze the difference in interferon-gamma (IFN-γ) production between QuantiFeron-TB Gold Plus TB1 and TB2 blood collection tubes in general and specific populations (Darmawan G, et al. Clin Chem Lab Med. Published online May 25, 2023. doi:10.1515/cclm-2023-0293)
Read More »Leica launches Bond ChromoPlex II Dual Detection kit
June 9, 2023—Leica Biosystems launched its Bond ChromoPlex II Dual Detection kit for use in immunohistochemistry and chromogenic in situ hybridization on Bond-Max and Bond-III instruments.
Read More »FDA clears Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
May 24, 2023—Hologic announced the FDA has granted 510(k) clearance for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
Read More »TriCore goes live with X-Lab’s Labgnostic
May 22, 2023—X-Lab announced that TriCore Reference Laboratories will go live with its product Labgnostic to transition TriCore's paper-based orders and results workflows to fully electronic workflows.
Read More »Siemens launches Atellica Hema analyzers
May 18, 2023—Siemens Healthineers launched two solutions for high-volume hematology testing, the Atellica Hema 570 analyzer and Atellica Hema 580 analyzer.
Read More »Preclinical medical students and pathologists: departing from the text
Despite diminishing classroom contact with medical students in the preclinical years, pathologists continue to be asked to teach year one and two students about the diseases delineated in textbooks. During this period, they should be alert to opportunities to also teach students about what pathologists actually do for patients on a daily basis. The shift toward exposure to the actual practice of pathology might increase students' interest in, and appreciation for, the specialty. Read more in "Preclinical medical students and pathologists: departing from the text" by Edward J. Gutmann, MD, director, cytopathology fellowship program, Dartmouth Hitchcock Medical Center and Dartmouth (Geisel) Medical School, in Cancer Cytopathology.
Read More »Zeus Scientific MTTT algorithm for Lyme disease detection
May 17, 2023—Zeus Scientific has introduced the Zeus Borrelia Modified Two-Tiered Testing (MTTT) algorithm, an FDA-cleared all-ELISA algorithm designed to improve the detection of early Lyme disease by up to 30 percent compared with the standard two-tiered testing algorithm.
Read More »Trane Technologies acquires Helmer Scientific
May 16, 2023—Trane Technologies has acquired Helmer Scientific.
Read More »Randox Laboratories introduces PSA, BNP control
May 12, 2023—Randox Labs has released two new products, a prostate-specific antigen and brain natriuretic peptide control.
Read More »Siemens to distribute Scopio digital cell morphology platforms
May 8, 2023—Siemens Healthineers announced it has entered into an agreement with Scopio Labs to distribute the Scopio X100 and Scopio X100HT.
Read More »Tempus gets FDA premarket approval for xT CDx
May 1, 2023—Tempus announced that the FDA has approved the company’s premarket approval application for its companion diagnostic test, xT CDx, to identify patients who may benefit from treatment with the targeted therapies listed in the product’s indications for use.
Read More »Kaiser Permanente, Geisinger to launch Risant Health
April 27, 2023—Kaiser Foundation Hospitals and Geisinger Health announced the launch of Risant Health and a definitive agreement to make Geisinger the first health system to join Risant to expand access to value-based care in communities across the country.
Read More »ZeptoMetrix introduces Protrol QC material
April 21, 2023—ZeptoMetrix introduced Protrol, a line of products designed to evaluate and monitor the performance of antigen-based assays, including lateral flow immunoassays for infectious diseases.
Read More »Bio-Rad launches Cardiac Advance quality controls
April 18, 2023–Bio-Rad Laboratories has launched Cardiac Advance, a four-level multianalyte cardiac quality control for high-sensitivity troponin testing.
Read More »SeraCare releases FFPE solid tumor CNV reference material
April 14, 2023—LGC SeraCare has developed a comprehensive solid tumor copy number variation reference material in a formalin-fixed, paraffin-embedded format.
Read More »ARUP chooses Gestalt’s PathFlow for digital pathology
April 13, 2023—ARUP Laboratories has selected Gestalt Diagnostics’ PathFlow digital platform to support its vision, ARUP says, for digital pathology.
Read More »Maine Molecular QC releases SpotFire RSP controls
April 10, 2023—Maine Molecular Quality Controls has released SpotFire RSP positive and negative controls for use as external assayed quality controls to monitor the performance of in vitro laboratory nucleic acid testing for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, adenovirus, seasonal coronavirus, SARS-CoV-2, human metapneumovirus, human rhinovirus/enterovirus, influenza A subtypes H1-2009 and H3, influenza B, parainfluenza virus, and RSV.
Read More »FDA clears Leica Biosystems MMR antibody panel
April 3, 2023—Leica Biosystems announced FDA 510(k) clearance of the Bond mismatch repair antibody panel for use in screening patients with colorectal cancer for the identification of Lynch syndrome.
Read More »Sarstedt launches NFT urine collection system
March 31, 2023—Sarstedt’s new Needle-Free Transfer Urine Collection System is a closed urine collection system for needle-free transfer of urine from the needle-free cup or urine collection container to a Urine Monovette.
Read More »Roche, Eli Lilly to develop Elecsys Amyloid Plasma Panel for Alzheimer’s
March 22, 2023—Roche has entered into a collaboration with Eli Lilly to support the development of Roche’s Elecsys Amyloid Plasma Panel.
Read More »Enzo Biochem to sell clinical lab to Labcorp
March 20, 2023—Enzo Biochem announced it has entered into an agreement in which Labcorp will acquire the assets of its clinical laboratory division, Enzo Clinical Labs.
Read More »BD gets FDA 510(k) clearance for vaginal panel on BD Cor system
March 16, 2023—BD announced it has received FDA 510(k) clearance for its BD Vaginal Panel on the BD Cor system.
Read More »FDA expands approval for Ventana PD-L1 (SP263) assay
March 13, 2023—Roche announced that the FDA has approved the Ventana PD-L1 (SP263) assay as a companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with Libtayo, a PD-1 inhibitor therapy developed by Regeneron.
Read More »Agilent announces global distribution agreement with Proscia
March 10, 2023—Agilent Technologies announced a multiyear distribution agreement with Proscia to offer a comprehensive digital diagnostic pathology system, combining Agilent’s pathology staining solutions with Proscia’s Concentriq Dx enterprise pathology platform.
Read More »FDA clears Abbott TBI lab-based blood test
March 9, 2023—Abbott has received FDA clearance for its Alinity i laboratory traumatic brain injury blood test.
Read More »Siemens and Sysmex sign OEM agreement
March 8, 2023—Siemens Healthineers signed a global OEM agreement on hemostasis products with Sysmex Corp.
Read More »Hamamatsu, Siemens to distribute whole slide scanners
March 7, 2023—Hamamatsu announced a multiyear distribution agreement with Siemens Healthineers.
Read More »Qiagen, Sophia Genetics partner to offer NGS solutions
March 1, 2023—Qiagen has launched its QIAseq Platform Partnership program and a partnership with Sophia Genetics that will bring together QIAseq reagent technology for next-generation sequencing with the Sophia DDM digital analytics platform.
Read More »Roche launches antibodies to ID mutations in brain cancer
Feb. 27, 2023—Roche launched the IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody and ATRX Rabbit Polyclonal Antibody to identify mutation status in patients who have brain cancer.
Read More »Globe Scientific introduces line of Globe/Euromex microscopes
Feb. 23, 2023—Globe Scientific has introduced a line of Globe/Euromex microscopes and microscope accessories.
Read More »FDA expands approval of BD Onclarity HPV assay
Feb. 21, 2023—BD announced FDA market approval for the Onclarity HPV assay to be used with the Hologic ThinPrep Pap test.
Read More »SeraCare releases HRD reference materials
Feb. 16, 2023—LGC SeraCare has developed three contrived, tumor-normal cell-line–derived homologous recombinant deficiency reference materials, Seraseq FFPE HRD High-Positive RM, Seraseq FFPE HRD Low-Positive RM, and Seraseq FFPE HRD Negative RM.
Read More »AscencioDx COVID-19 test, molecular detector get EUA
Feb. 14, 2023—Anavasi Diagnostics announced FDA emergency use authorization for its AscencioDx COVID-19 test and AscencioDx molecular detector for use in point-of-care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation.
Read More »BioFire SpotFire system and panel get 510(k) clearance
Feb. 8, 2023—BioMérieux has received FDA 510(k) clearance and a CLIA waiver for its BioFire SpotFire system and respiratory panel.
Read More »Stemline’s Orserdu approved for patients with ESR1 mutations
Jan. 31, 2023—The U.S. Food and Drug Administration has approved Stemline Therapeutics’ Orserdu (elacestrant) for the treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Read More »Congress nixes national patient identifier—again
Jan. 30, 2023—Congress once more failed to embrace movement towards a national patient identification system, leaving in place a ban on using federal funds to promote or adopt NPI standards in the omnibus fiscal year 2023 spending bill.
Read More »Qiagen launches EZ2 Connect MDx for diagnostic use
Jan. 19, 2023—Qiagen has launched its EZ2 Connect MDx for use in diagnostic laboratories.
Read More »Agilent, Akoya Biosciences to develop multiplex IHC solutions
Jan. 17, 2023—Agilent Technologies announced a partnership with Akoya Biosciences to develop chromogenic and immunofluorescent multiplex assays that include spatial analysis for biopharma companies developing precision cancer therapeutics.
Read More »On display: pathology resident’s art in honor of friend
The photography collection of Leonard Yenwongfai, MD, MS, a third-year pathology resident at the University of Kentucky College of Medicine, was selected for display at the Arts in HealthCare North Gallery located in the Kentucky Clinic, part of the UK hospital. His collection of flowers and insect life is titled “Patterns and Pollinators” and was born of concern for a friend who had been diagnosed in 2020 at UK with bulbar amyotrophic lateral sclerosis and missed spending time outdoors. Read the UK HealthCare article here.
Read More »Primary medical care in transition
Bruce A. Friedman, MD, emeritus professor of informatics, Department of Pathology, University of Michigan Medical School, and member of LigoLab Information Systems' advisory board, has written an opinion piece titled "Primary Medical Care in Transition: Effects on the Lab Test Ordering Market." Read the piece here.
Read More »Qiagen, Helix partner to advance CDx for hereditary diseases
Jan. 6, 2023—Qiagen announced an exclusive strategic partnership with Helix to advance companion diagnostics for hereditary diseases.
Read More »Xifin white paper: a guide to molecular Dx market-share expansion
Xifin released a white paper titled "The Executive's Guide to Molecular Diagnostic Market-Share Expansion: Critical Success Factors for Maximizing Revenue, Patient Access, and Physician Engagement." Authors Kyle Fetter, chief operating officer, and Harley Ross, chief commercial officer, offer practical approaches, process enhancements, and payor strategies essential to growing novel diagnostic market share through proactive, purposeful, and technologically enabled engagements with patients, physicians, and payors. Download the white paper here.
Read More »FDA approves FoundationOne Liquid CDx for a group of TKIs
Dec. 28, 2022—The FDA has approved Foundation Medicine's FoundationOne Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of tyrosine kinase inhibitors approved by the FDA for this indication
Read More »Thermo Fisher launches TrueMark infectious disease panels
Dec. 16, 2022—Thermo Fisher Scientific launched TrueMark Infectious Disease Research Panels.
Read More »FDA approves Qiagen CDx for NSCLC
Dec. 14, 2022—Qiagen announced FDA approval of its Therascreen KRAS RGQ PCR kit as a companion diagnostic test to aid in identifying non-small cell lung cancer patients eligible for treatment with adagrasib (Krazati, Mirati Therapeutics).
Read More »CompuGroup acquires Medicus Laboratory Information Systems
Dec. 9, 2022—CompuGroup Medical US announced the acquisition of Medicus Laboratory Information Systems from Diagnostic Systems Consulting LLC.
Read More »FDA clears Roche Alzheimer’s disease CSF assays
Dec. 8, 2022—Roche announced FDA 510(k) clearance of its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays.
Read More »FDA clears HemoSonics Quantra with QStat cartridge
Dec. 1, 2022—HemoSonics received FDA 510(k) clearance for the Quantra hemostasis system with QStat cartridge.
Read More »General Data launches LaserTrack Flex for histology labs
Nov. 29, 2022—General Data Healthcare launched its LaserTrack Flex cassette printer.
Read More »SeraCare launches NGS reference material for BRCA
Nov. 22, 2022—LGC SeraCare announced the availability of its Seraseq FFPE BRCA1/2 LGR Reference Material intended for use with next-generation sequencing assays or amplified nucleic-acid-based methods that identify somatic and germline variants in the BRCA1 and BRCA2 genes.
Read More »FDA approves Ventana CDx to ID patients eligible for Elahere
Nov. 17, 2022—Roche announced FDA approval of the Ventana FOLR1 (FOLR1-2.1) RxDx assay, the first immunohistochemistry companion diagnostic test to aid in identifying epithelial ovarian cancer patients who are eligible for targeted treatment with Elahere (mirvetuximab soravtansine-gynx).
Read More »FDA OKs PerkinElmer Eonis kit for SMA screening in newborns
Nov. 16, 2022—PerkinElmer announced that the FDA has authorized the marketing of its Eonis SCID-SMA assay kit for in vitro diagnostic use by certified laboratories for the detection of spinal muscular atrophy and severe combined immunodeficiency in newborns.
Read More »Roche launches antibody to identify PRAME protein expression
Nov. 15, 2022—Roche has launched its Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from patients who are suspected of having melanoma.
Read More »FDA clears Simplexa Congenital CMV Direct assay
Nov. 11, 2022—DiaSorin announced it has received FDA 510(k) clearance for its Simplexa Congenital CMV Direct kit.
Read More »ZeptoMetrix launches NATtrol MS2 bacteriophage stock
Nov. 10, 2022—ZeptoMetrix launched its NATtrol MS2 Bacteriophage quantitative stock, intended for use as an internal process control for rt-PCR assays.
Read More »Roche introduces Cobas 5800 system
Nov. 9, 2022—Roche announced plans for the U.S. launch of the Cobas 5800 system, a compact, fully-automated molecular instrument that aims to offer a flexible, PCR testing solution to help clinicians diagnose infectious diseases.
Read More »Werfen to acquire Immucor
Nov. 4, 2022—Werfen announced it has agreed to acquire Immucor from asset management firm TPG.
Read More »Thermo Fisher Scientific buys Binding Site
Oct. 31, 2022—Thermo Fisher Scientific announced today that it has entered into a definitive agreement to acquire the Binding Site Group from a shareholder group led by European private equity firm Nordic Capital.
Read More »Bio-Rad launches Exact Diagnostics CT/NG, STI run controls
Oct. 28, 2022—Bio-Rad Laboratories has launched two Exact Diagnostics products, CT/NG Positive Run Control, intended to be used with Chlamydia trachomatis and Neisseria gonorrhoeae molecular assays, and STI Negative Run Control, which monitors the absence of Chlamydia trachomatis and Neisseria gonorrhoeae in various molecular assays, the company says, and can be used to detect errors in laboratory testing procedures, including potential contamination events, while controlling for sample adequacy assessment.
Read More »FDA clears COVID-19 PCR test on Cobas 6800/8800 systems
Oct. 25, 2022—Roche announced that the FDA has granted 510(k) clearance for the Cobas SARS-CoV-2 Qualitative PCR test for use on the automated Cobas 6800 and Cobas 8800 systems.
Read More »ZeptoMetrix launches molecular QCs for women’s health
Oct. 19, 2022—ZeptoMetrix launched two vaginal molecular QC controls, NATtrol Vaginal Positive Control and NATtrol Vaginal Negative Control, for in vitro diagnostic use.
Read More »Indica, Hamamatsu to provide integrated DP workflows
Oct. 18, 2022—Indica Labs and Hamamatsu Photonics announced an agreement to maintain long-term interoperability between Indica Labs’ Halo AP software platform and Hamamatsu’s NanoZoomer series of scanners.
Read More »Sebia acquires Zeus Scientific
Oct. 17, 2022—Sebia announced the acquisition of Zeus Scientific, an in vitro diagnostic company based in Branchburg, NJ.
Read More »Bio-Rad introduces Unity Next Peer QC
Oct. 14, 2022—Bio-Rad Laboratories has launched Unity Next Peer QC, a quality control peer comparison software that provides instant access to peer reporting and comprehensive quality control data.
Read More »ZeptoMetrix releases flu, RSV, SARS-CoV-2 external run control
Oct. 13, 2022—ZeptoMetrix has released its NATtrol external run control for flu A and B, RSV B, and SARS-CoV-2, for research use only.
Read More »mTuitive, Gestalt partner to enhance pathology reporting
Oct. 11, 2022—mTuitive and Gestalt Diagnostics announced a partnership to enhance reporting for pathology laboratories.
Read More »FDA clears NanoZoomer S360MD slide scanner system
Oct. 10, 2022—Hamamatsu Photonics announced that the FDA granted 510(k) clearance to market the NanoZoomer S360MD high-throughput, automated slide scanner system for primary diagnostic use.
Read More »Randox releases MRSA/MSSA PCR test on Vivalytic system
Oct. 7, 2022—Randox Laboratories has added its MRSA/SA test to the Vivalytic system.
Read More »FDA clears Boston Cell Standards IHC controls for HER2, ER, PR
Oct. 6, 2022—Boston Cell Standards today announced it received 510(k) clearance from the FDA for its IHControls breast cancer panel, positive controls to monitor the performance of the immunohistochemical staining process for HER2, ER, and PR IHC assays.
Read More »Roche CDx approved to ID patients eligible for Enhertu
Oct. 5, 2022—Roche announced that the FDA has approved the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with HER2-low metastatic breast cancer for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. Enhertu is a specifically engineered HER2-directed antibody drug conjugate developed and commercialized by AstraZeneca and Daiichi Sankyo.
Read More »NovoPath adds capabilities to NovoPath 360
Oct. 3, 2022—NovoPath today announced the release of enhanced integrated workflows to its software-as-a-service–based LIS platform, NovoPath 360.
Read More »Illumina unveils NovaSeq X series
Sept. 29, 2022—Illumina today announced the launch of the NovaSeq X series—NovaSeq X and NovaSeq X Plus—production-scale sequencers, which aim to enable faster, more powerful, and more sustainable sequencing.
Read More »Oncomine Dx Target test approved to ID patients for Retevmo
Sept. 28, 2022—The FDA has approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to aid in selecting patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer, RET-fusion positive advanced or metastatic thyroid cancer, and RET-mutation positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).
Read More »FDA approves T-Cell Select to automate TB testing
Sept. 22, 2022—Oxford Immunotec, a division of PerkinElmer, announced FDA approval of its T-Cell Select reagent kit for automating the company’s T-SPOT.TB test workflow for in vitro diagnostic use by certified laboratories.
Read More »Digital Pathology Connections debuts at PathVisions 2022
Digital Pathology Connections, a worldwide community for professionals interested in the digital future of the anatomic pathology laboratory, debuted at the Pathology Visions 2022 conference, held in Las Vegas, Oct. 16–18. Digital Pathology Connections (DPC) is a virtual community providing educational content and enabling discussions on trending topics in pathology.
Read More »FDA clears Roche Cobas Pure for low- to mid-vol labs
Sept. 19, 2022—Roche received FDA 510(k) clearance for the Cobas Pure, a compact and modular solution that combines clinical chemistry, immunoassay, and ion-selective electrode diagnostic testing on a single platform with a footprint of about 21 square feet.
Read More »FDA clears DiaSorin Simplexa COVID-19 test
Sept. 14, 2022—DiaSorin received 510(k) clearance from the FDA for its Simplexa COVID-19 Direct kit.
Read More »NovoPath, FrontRunnerHC to extend NovoPath 360 capabilities
Sept. 7, 2022—NovoPath has signed a resellers agreement with FrontRunnerHC, a software provider that aims to help health care organizations maximize reimbursements with data automation solutions that provide accurate patient demographic, insurance, and financial information.
Read More »Specific Reveal AST system designated a breakthrough device
Aug. 24, 2022—BioMérieux announced that its Specific Reveal rapid antimicrobial susceptibility test system has received a breakthrough device designation from the FDA.
Read More »Guardant360 CDx OK’d as companion diagnostic for Enhertu
Aug. 23, 2022–Guardant Health announced that the FDA has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic to select patients with unresectable or metastatic HER2 (ERBB2)-mutant non-small cell lung cancer whose tumors have activating HER2 mutations (single nucleotide variants and exon 20 insertions) for treatment with Enhertu
Read More »Roche’s COVID-19 test detects, differentiates BA.2.75
Aug. 22, 2022—Roche and its subsidiary TIB Molbiol have developed a COVID-19 test for researchers that detects and differentiates the BA.2.75 subvariant.
Read More »Study: Abbott’s TBI test could predict brain injury outcomes
Aug. 19, 2022—Abbott announced that a study published in Lancet Neurology demonstrates the ability of two blood-based biomarkers to predict how a person will recover from traumatic brain injury (TBI) (Korley FK, et al. Lancet Neurol. 2022;21[9]:803–813).
Read More »BD, Accelerate announce worldwide commercial collaboration
Aug. 17, 2022—BD and Accelerate Diagnostics announced a worldwide commercial collaboration agreement in which BD will offer Accelerate’s rapid testing solution for antibiotic resistance and susceptibility.
Read More »NGS-based CDx approved to ID candidates for Enhertu
Aug. 16, 2022—The FDA granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target test as a companion diagnostic to identify patients whose tumors have HER2 (ERBB2)-activating mutations (single nucleotide variants and exon 20 insertion) in non-small cell lung cancer who may be candidates for Enhertu (fam-trastuzumab deruxtecan-nxki).
Read More »Roche Ventana MMR RxDx gets expanded approval
Aug. 15, 2022—Roche announced that the FDA has approved a label expansion for the Ventana MMR RxDx panel, an immunohistochemistry companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA mismatch repair (dMMR) and who may be eligible for Keytruda (pembrolizumab).
Read More »FDA clears BioMérieux Nephrocheck test on Vidas platform
July 29, 2022—The FDA has cleared the BioMérieux Vidas Nephrocheck assay, for use to detect kidney stress in patients at risk of acute kidney injury.
Read More »CellaVision launches Diff-Line for low-vol hematology labs
July 27, 2022—CellaVision announced today at the AACC meeting the launch of its Diff-Line by CellaVision, a workflow solution for low-volume hematology laboratories.
Read More »Roche amyloid plasma panel designated a breakthrough device
July 20, 2022—Roche announced yesterday that the FDA has granted breakthrough device designation to the Elecsys Amyloid Plasma Panel.
Read More »Bio-Rad launches two negative run controls
July 14, 2022—Bio-Rad Laboratories launched two new Exact Diagnostics negative run controls.
Read More »Thermo Scientific, Inpeco to develop LC-MS, TLA connectivity
July 13, 2022—Thermo Fisher Scientific announced an agreement with Inpeco S.A. to develop connectivity between the Thermo Scientific Cascadion SM automated liquid chromatography mass spectrometer and the Inpeco FlexLab total laboratory automation system.
Read More »Paige HER2Complete gets CE-IVD, UKCA marks
June 30, 2022—Paige has received CE-IVD and UKCA (UK Conformity Assessed) marks for its HER2Complete artificial intelligence software.
Read More »Streck introduces viral extraction kit
June 28, 2022—Streck, in partnership with Ceres Nanosciences, announced the availability of its viral extraction kit for clinical samples containing SARS-CoV-2 and influenza A.
Read More »Tribun Health releases redesigned TeleSlide Patho 5
June 27, 2022—Tribun Health has released its redesigned TeleSlide Patho 5, an online telepathology platform for sharing digital pathology slides and other multimedia documents to obtain a second opinion.
Read More »AMA announces new CPT digital pathology codes
June 22, 2022—The CAP has worked with the American Medical Association CPT Editorial Panel to add 13 new digital pathology add-on codes. The new digital pathology category three CPT codes will be used to report additional clinical staff work and service requirements associated with digitizing glass microscope slides for primary diagnosis. The AMA CPT will also add a new heading ...
Read More »FDA clears Scopio Labs digital cell morphology platform
June 17, 2022—Scopio Labs received FDA 510(k) clearance for its X100HT hematology digital cell morphology platform with peripheral blood smear review.
Read More »Sysmex gets FDA clearance for residual WBC counting
June 15, 2022—The FDA has cleared residual white blood cell counting on Sysmex America’s XN-10 Automated Hematology Analyzer with Blood Bank mode.
Read More »Intermountain selects Gestalt, Hamamatsu for digital pathology
June 10, 2022—Intermountain Healthcare has chosen Gestalt Diagnostics and Hamamatsu Photonics to implement digital pathology across its health care system.
Read More »Sarstedt introduces CSF false-bottom tube
June 8, 2022—Sarstedt announced the availability of a false-bottom tube for cerebrospinal fluid with an elevated conical base.
Read More »Leica launches Bond-Prime staining platform
May 31, 2022—Leica Biosystems launched Bond-Prime, a high-speed immunohistochemistry and in situ hybridization staining platform.
Read More »Bio-Rad launches CFX Duet Real-Time PCR system
May 26, 2022—Bio-Rad Laboratories has launched the CFX Duet Real-Time PCR system to support researchers in developing singleplex and duplex quantitative PCR assays.
Read More »BD launches infectious disease molecular Dx platform
May 23, 2022—BD announced the U.S. launch of its fully automated, high-throughput infectious disease molecular diagnostics platform, the BD COR MX.
Read More »FDA approves Enhertu for breast cancer
May 18, 2022—Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the United States for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Read More »FDA approves Hologic Aptima CMV Quant assay
May 16, 2022—Hologic announced that the FDA approved its Aptima CMV Quant assay to quantify the viral load of cytomegalovirus in patients who have had solid organ or stem cell transplants.
Read More »Abbott’s STI assay gets FDA clearance
May 13, 2022—Abbott has received FDA clearance for its Alinity m STI assay.
Read More »FDA authorizes Fujirebio test for Alzheimer disease
May 11, 2022—Fujirebio Diagnostics announced that the FDA has granted de novo marketing authorization for its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for assessing β-amyloid pathology in patients who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
Read More »BioFire joint infection panel gets de novo authorization
May 9, 2022—BioMérieux’s BioFire joint infection panel has received FDA de novo authorization.
Read More »Tribun Health enters pharmaceutical market
April 27, 2022—Tribun Health, formerly Tribvn Healthcare, announced its expansion into the pharmaceutical market with the appointment of Loic Dartois as vice president of pharma.
Read More »Accelerate Diagnostics presents performance data at ECCMID
April 22, 2022—Accelerate Diagnostics announced the release of new performance data on the Accelerate Arc module and blood culture kit.
Read More »Versant Dx launches strategy to accelerate digital pathology
April 21, 2022—Versant Diagnostics has announced a strategy to "drive the digital revolution in pathology," with a focus on anatomic pathology, precision medicine, and the digital transformation of the industry.
Read More »PreciseDx AI-enabled digital pathology detects Parkinson’s
April 20, 2022—PreciseDx today announced its artificial intelligence–enabled digital pathology technology can accurately diagnose Parkinson's disease in patients prior to the severe onset of symptoms.
Read More »FDA authorizes COVID-19 breathalyzer test
April 15, 2022—The FDA issued an emergency use authorization to InspectIR Systems for its InspectIR COVID-19 Breathalyzer test.
Read More »BioMérieux acquires Specific Diagnostics
April 12, 2022—BioMérieux has entered into an agreement to acquire Specific Diagnostics, a privately held U.S.-based company that developed a rapid antimicrobial susceptibility test system.
Read More »Tempus unveils Edge pathology-driven AI platform
April 1, 2022—Tempus has announced plans to launch Edge, a platform that will enable pathology practices to access the company’s digital pathology AI models, during the second half of this year.
Read More »Accelerate Diagnostics launches Arc module, BC kit
March 28, 2022—Accelerate Diagnostics launched the Accelerate Arc system for rapid and accurate microbial identification of positive blood cultures.
Read More »BioMérieux gets FDA 510(k) clearance for Vitek MS Prime
March 18, 2022—BioMérieux announced the Vitek MS Prime, its new MALDI-TOF mass spectrometry identification system, received FDA 510(k) clearance.
Read More »CE-marked Nova Max Pro creatinine/eGFR meter launched
March 11, 2022—Nova Biomedical launched the CE-marked Nova Max Pro creatinine/eGFR meter system in the EU market.
Read More »Opdivo + chemo approved as neoadjuvant treatment for NSCLC
March 9, 2022—The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting.
Read More »Paragon Genomics unveils Emerging Variant Add-on V2
Feb. 24, 2022—Paragon Genomics announced the release of its Emerging Variant Add-on V2.
Read More »Tribun Health nabs KLAS award for digital pathology
Feb. 22, 2022—Tribun Health announced it won a 2022 “Best in KLAS” award for digital pathology in Europe.
Read More »Always and Never: Words not meant for the practice of medicine, the laboratory, or a pandemic
As a first-year medical student, once a week my small group would meet with an attending physician to learn how to talk to patients respectfully and document that conversation in the history and physical examination. In those early years of medical school, my time was mostly spent in lecture halls, gross anatomy and microanatomy labs, and the library studying, so these weekly meetings held all the promise and anticipation of what practicing medicine and actually treating patients would bring. In one of those meetings, our leader made a comment that had a lasting impression: the words “always” and “never” have no place in the dialogue of strong science and the practice of good medicine. Always and never. Two words at opposite ends of a spectrum that imply absolute certainty.
Read More »FDA clears Streck MDx-Chex for BCID2
Jan. 31, 2022—Streck’s MDx-Chex for BCID2, a quality control designed to meet the standards for verifying the performance of the BioFire BCID2 panel assay for sepsis, has been granted FDA clearance for in vitro diagnostics use.
Read More »Biodesix launches GeneStrat NGS, IQLung testing strategy
Jan. 28, 2022—Biodesix announced the launch of its GeneStrat NGS genomic test, a blood-based tumor profiling test.
Read More »Siemens launches Enhanced Liver Fibrosis test in U.S.
Jan. 26, 2022—Siemens Healthineers' Enhanced Liver Fibrosis test is now available in the United States.
Read More »DiaSorin updates RUO Simplexa SARS-CoV-2 Variants Direct
Jan. 14, 2022—DiaSorin Molecular has released an updated version of its Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable the detection of mutations associated with the omicron variant (B.1.1.529).
Read More »Quidel to acquire Ortho Clinical Diagnostics
Dec. 27, 2021—Quidel and Ortho Clinical Diagnostics have entered into a definitive agreement in which Quidel will acquire Ortho for $24.68 per share of common stock for a total consideration of about $6.0 billion.
Read More »Streck launches QC for sepsis
Dec. 24, 2021—Streck announced the availability of its MDx-Chex for BCID2 quality control, designed to meet the standards for verifying the performance of sample-to-result molecular tests for sepsis.
Read More »Bio-Rad SARS-CoV-2 variant neutralization antibody assays
Dec. 20, 2021—Bio-Rad Laboratories launched the Bio-Plex Pro Human SARS-CoV-2 Variant Neutralization Antibody Assays, for research use only.
Read More »Siemens SARS-CoV-2 testing portfolio detects omicron variant
Dec. 15, 2021—Siemens Healthineers has announced that the company’s SARS-CoV-2 tests are designed to detect the SARS-CoV-2 omicron variant.
Read More »Seegene unveils PCR test that IDs omicron, VOCs in one tube
Dec. 13, 2021—Seegene unveiled the Novaplex SARS-CoV-2 Variants VII assay for research use only.
Read More »Roche AI-based digital pathology algorithms for breast cancer
Dec. 9, 2021—Roche announced the launch of three research use only automated digital pathology algorithms, uPath Ki-67 (30-9), uPath ER (SP1), and uPath PR (1E2) image analysis for breast cancer.
Read More »Orchard Software releases white paper on molecular POC testing
Orchard Software released a white paper titled “The Rise of Molecular Point-of-Care Testing: Where Does Molecular POCT Fit in the Diagnostic Continuum?” The paper offers an overview of molecular testing, discusses infectious disease testing and molecular POC tests for COVID-19, and provides Orchard software solutions for molecular and POC testing. Read the white paper here.
Read More »SeptiCyte Rapid receives 510(k) clearance
Dec. 3, 2021—Biocartis announced that the FDA granted 510(k) clearance for its SeptiCyte Rapid test, which was developed under partnership with Immunexpress.
Read More »Olympus’ first results of AI-based Dx tool for gastric cancer
Dec. 1, 2021–Results of Olympus’ ongoing joint research program to create an AI-based pathology diagnostic tool were announced at the Japan Society of Digital Pathology Study annual meeting.
Read More »FDA approves of QuantiFeron-TB Gold Plus on Liaison XS
Nov. 29, 2021—Qiagen announced that the FDA has approved the Liaison QuantiFeron-TB Gold Plus assay for use on DiaSorin’s automated Liaison XS platform.
Read More »Bio-Rad adds SARS-CoV-2 S gene delta-kappa variants control
Nov. 24, 2021—Bio-Rad Laboratories has launched its Exact Diagnostics SARS-CoV-2 S Gene Delta-Kappa Variants Control for research testing. The control includes lineages B.1.617.1, B.1.617.2 (AY sublineages), and B.1.617.3.
Read More »Microbix expands pandemic test controls portfolio
Nov. 22, 2021—Microbix Biosystems has expanded its portfolio of Quality Assessment Products to include controls that support PCR tests for four major variants of concern of SARS-CoV-2.
Read More »Cobas 5800 molecular Dx system launched in CE markets
Nov. 18, 2021—Roche launched its Cobas 5800 system in countries accepting the CE mark.
Read More »LumiraDx’s COVID-19 antigen test gets expanded EUA
Nov. 5, 2021—LumiraDx announced that the FDA’s emergency use authorization for its SARS-CoV-2 antigen test has been expanded to include screening of asymptomatic individuals.
Read More »FDA grants EUA for Lighthouse’s COVID-19 assay
Nov. 3, 2021—Lighthouse Lab Services announced that the FDA has granted emergency use authorization for its CovidNow SARS-CoV-2 assay kit. The EUA covers use for symptomatic and asymptomatic patients with a provider’s order.
Read More »Bio-Rad launches enhanced Liquichek diabetes control
Nov. 1, 2021—Bio-Rad Laboratories launched an enhanced version of its Liquichek Diabetes Control.
Read More »Hologic’s multiplex COVID-19/flu test now available
Oct. 29, 2021—Hologic announced that its Aptima SARS-CoV-2/Flu assay is available for the simultaneous detection and differentiation of three respiratory viruses that can present with overlapping clinical symptoms.
Read More »Bio-Rad launches CFX Opus Dx RT-PCR detection systems
Oct. 27, 2021—Bio-Rad Laboratories launched its CFX Opus 96 Dx and CFX Opus 384 Dx systems, real-time PCR detection systems that have been listed with the FDA for IVD testing and that meet the CE-IVD requirement for IVD use in Europe.
Read More »Labcon awarded $59.3 million to increase pipette production
Oct. 25, 2021—Labcon North America, a wholly owned subsidiary of Helena Laboratories, has announced a $59.3 million contract award from the U.S. Department of Defense in coordination with the U.S. Department of Health and Human Services.
Read More »Hardy Diagnostics releases HardyChrom Candida + auris
Oct. 21, 2021—Hardy Diagnostics has released its HardyChrom Candida + auris, a chromogenic media recommended for the selective isolation and differential identification of Candida species.
Read More »LumiraDx submits SARS-CoV-2/flu A/B antigen test for EUA
Oct. 18, 2021—LumiraDx has submitted the LumiraDx SARS-CoV-2 & Flu A/B Test to the Food and Drug Administration for emergency use authorization.
Read More »Beckman launches DxU Iris Workcell urinalysis solution
Oct. 15, 2021—Beckman Coulter launched at this year’s AACC Annual Scientific Meeting and Clinical Lab Expo its DxU Iris Workcell, a fully automated system designed for high-volume laboratories that streamlines urinalysis workflow and reduces manual reviews to four percent.
Read More »PerkinElmer SARS-CoV-2 respiratory panel, ELISA get EUA
Oct. 13, 2021—PerkinElmer announced that the FDA has issued emergency use authorization for its PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay.
Read More »Join our webinar “Those Sticky, Tricky platelets – Solving the Puzzle of Platelet Clumping”
Sysmex America will host a webinar titled “Those sticky, tricky platelets—solving the puzzle of platelet clumping” on Oct. 20, beginning at 12 pm Central time. The session will review methods for performing platelet counts as part of a CBC. The presenter, Becky Socha, MS, MLS(ASCP)CM, BB(ASCP)CM, of Mercy Medical Center in Baltimore, will discuss scenarios for handling specimens with thrombocytopenia and how to troubleshoot EDTA-induced pseudothrombocytopenia. Other objectives of the webinar include how to recognize normal and abnormal platelet histograms and scattergrams, and how to recognize spurious versus abnormal platelet results and how to troubleshoot them.
Read More »Bio-Rad adds SARS-CoV-2 to RP positive run control
Oct. 11, 2021—Bio-Rad announced its Exact Diagnostics RP Positive Run Control for syndromic respiratory panels is now available with inactivated whole virus for SARS-CoV-2.
Read More »Sysmex introduces hematology analyzer for malaria detection
Oct. 1, 2021—Sysmex America has introduced its XN-30 research use only automated hematology analyzer for malaria detection. The analyzer differentiates P. falciparum from non-falciparum species and determines the life-cycle staging of the parasites detected.
Read More »Bio-Rad launches IgA, IgM SARS-CoV-2 Bio-Plex Pro panels
Sept. 30, 2021—Bio-Rad Laboratories launched its Bio-Plex Pro Human IgA and IgM SARS-CoV-2 panels to detect IgA and IgM antibodies against four SARS-CoV-2 antigens.
Read More »Seegene unveils molecular testing system
Sept. 29, 2021—Seegene unveiled its first fully automated PCR testing system, Starlet-AIOS, at the 2021 AACC annual meeting, Sept. 26–30, in Atlanta.
Read More »Paige Prostate software receives FDA approval
Sept. 23, 2021—The FDA authorized marketing of Paige's software Paige Prostate, a prostate cancer detection solution that identifies foci suspicious for cancer and provides this information to a pathologist.
Read More »Simplexa COVID-19, flu A/B assay assay gets CE mark
Sept. 21, 2021—DiaSorin Molecular announced that it has CE marked its Simplexa COVID-19 and Flu A/B Direct kit.
Read More »FDA clears test that differentiates bacterial, viral infections
Sept. 20, 2021—MeMed announced FDA 510(k) clearance for use of the company’s MeMed BV test on the MeMed Key platform to help health care providers distinguish between bacterial and viral infections.
Read More »PreciseMDX introduces digital health platform
Aug. 31, 2021—PreciseMDX introduced a cloud-based solution that enables labs to set up scalable, personalized, digital experiences.
Read More »Visby gets FDA clearance, CLIA waiver for POC STI test
Aug. 30, 2021—Visby Medical announced it has received FDA 510(k) clearance and was granted a CLIA waiver to market its single-use PCR diagnostic test for the multiplexed detection of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis using a self-collected vaginal swab.
Read More »FDA approves Oncomine Dx Target test as a CDx for Tibsovo
Aug. 27, 2021—The FDA has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target test as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 mutated cholangiocarcinoma who may be candidates for Tibsovo (ivosidenib tablets).
Read More »BD launches high-throughput molecular dx platform in the U.S.
Aug. 26, 2021—BD has launched its FDA-approved BD COR PX/GX system, a fully automated, high-throughput diagnostic platform that integrates robotics and sample management software algorithms to automate the complete molecular laboratory workflow from sample processing to diagnostic test result.
Read More »FDA grants marketing authorization to Siemens ELF test
Aug. 25, 2021—Siemens Healthineers announced that its Enhanced Liver Fibrosis test was granted marketing authorization under the de novo review pathway.
Read More »Hardy Diagnostics releases group A strep agar
Aug. 24, 2021—Hardy Diagnostics has released its HardyChrom Group A Strep agar, a chromogenic medium recommended for the selective cultivation and differentiation of group A streptococcus from clinical specimens.
Read More »Siemens launches two Sysmex hemostasis systems
Aug. 16, 2021—Siemens Healthineers has launched Sysmex's CN-3000 and CN-6000 hemostasis systems for mid- and high-volume coagulation testing.
Read More »Bio-Rad launches SARS-CoV-2 S gene variant controls
Aug. 13, 2021—Bio-Rad Laboratories has launched SARS-CoV-2 S gene alpha, beta, gamma, and epsilon variant controls.
Read More »Siemens unveils AI-based COVID-19 severity algorithm
Aug. 12, 2021—Siemens Healthineers has developed the Atellica COVID-19 Severity Algorithm, a model designed to help predict the potential likelihood of progression to severe disease and life-threatening multiorgan dysfunction in COVID-19 patients.
Read More »Qiagen’s rapid, portable SARS-CoV-2 antigen test gets EUA
Aug. 6, 2021—Qiagen received emergency use authorization from the FDA for its QIAreach SARS CoV-2 Antigen Test.
Read More »Immunovia pancreatic test gets CLIA approval
Aug. 4, 2021—Immunovia has received approval to begin patient testing for the IMMray PanCan-d blood test for the early detection of pancreatic cancer.
Read More »FDA clears Promega OncoMate MSI Dx system
July 29, 2021—Promega’s OncoMate MSI Dx analysis system has been cleared by the FDA as an IVD medical device to determine microsatellite instability status in colorectal cancer tumors.
Read More »Sarstedt introduces BL 1200 bulk sorter
July 20, 2021—Sarstedt introduced its BL 1200 Sort Connect, a preanalytical accessioning and sorting instrument that can be connected to integrated systems or analyzer lines.
Read More »Werfen companies now under one name, brand
July 15, 2021—Werfen announced that its companies, including Instrumentation Laboratory, Inova Diagnostics, and Biokit, are uniting under one name and one brand—Werfen—and a new corporate logo.
Read More »Bio-Rad launches SARS-CoV-2/FluA/FluB RT-PCR Kit in Europe
July 14, 2021—Bio-Rad launched its Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit (IVD) for European markets after having met the CE-IVD mark requirements.
Read More »Bruker launches products for MALDI Biotyper at ECCMID 2021
July 12, 2021—Bruker launched, at the 31st European Congress of Clinical Microbiology and Infectious Diseases products, and methods for its MALDI Biotyper platform.
Read More »FDA authorizes first quantitative serology test
July 9, 2021—Today the FDA issued an emergency use authorization to Ortho Clinical Diagnostics for the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative test.
Read More »Inova announces FDA 510(k) clearance for its Aptiva system
June 29, 2021–Inova Diagnostics announced FDA 510(k) clearance of its Aptiva system and Aptiva Celiac Disease IgA assay.
Read More »Thermo Fisher launches TaqPath COVID-19 2.0 test
June 24, 2021—Thermo Fisher Scientific launched its CE-IVD-marked TaqPath COVID-19 Fast PCR Combo Kit 2.0.
Read More »Biocept, Quest to provide testing for lung cancer patients
June 23, 2021—Biocept announced a collaboration with Quest Diagnostics to provide laboratory testing services to Quest patients for its Target Selector NGS-based liquid biopsy targeted lung cancer panel.
Read More »Epredia, Aiforia to distribute AI-based pathology software
June 22, 2021—Epredia and Aiforia announced they have entered into a commercial distribution agreement for Aiforia’s portfolio of preclinical and clinical pathology tools.
Read More »LGC SeraCare releases two blood TMB reference standards
June 21, 2021—LGC SeraCare released two new blood tumor mutational burden reference standards, Seraseq Blood TMB Score 7 and Seraseq Blood TMB Score 26.
Read More »Roche test gets EUA for symptomatic, asymptomatic people
June 18, 2021—Roche announced that the FDA granted emergency use authorization for the Cobas SARS-CoV-2 Nucleic acid test for use on the Cobas Liat System.
Read More »FDA approves avapritinib for advanced systemic mastocytosis
June 17, 2021—Blueprint Medicines announced that the FDA approved Ayvakit (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis, including aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.
Read More »Grail introduces Galleri multicancer early detection blood test
June 14, 2021—Grail introduced its Galleri multicancer early detection blood test, intended for use in people with an elevated risk of cancer, such as adults aged 50 or older, and as a complement to single-cancer screening tests.
Read More »Labcorp, OmniSeq launch Insight NGS genomic profiling test
June 10, 2021—Labcorp and OmniSeq announced the launch of OmniSeq Insight, a next-generation–sequencing, pan-cancer, solid tumor test that combines genomic and immune profiling, including tumor mutational burden, microsatellite instability, and immune gene expression.
Read More »Sysmex America adds XN-10 blood bank mode to its portfolio
June 9, 2021—Sysmex America has added the FDA-cleared XN-10 Automated Hematology Analyzer with Blood Bank mode to its portfolio of hematology solutions.
Read More »Diazyme launches beta-hydroxybutyrate assay
June 8, 2021—Diazyme launched its FDA 510(k)–exempt Beta-Hydroxybutyrate Assay for the quantitative determination of beta-hydroxybutyrate.
Read More »Lumakras OK’d for patients with KRAS G12C-mutated NSCLC
June 7, 2021—Amgen announced that the FDA approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Read More »FDA approves targeted therapy for subset of NSCLC
May 28, 2021—The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 20 insertion mutations.
Read More »DiaSorin releases Simplexa SARS-CoV-2 Variants Direct assay
May 25, 2021—DiaSorin Molecular has released the Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable the detection and discrimination of four SARS-CoV-2 mutations associated with circulating virus variants without requiring upfront RNA extraction.
Read More »Hologic receives approval for ThinPrep Genesis
May 24, 2021—Hologic announced the FDA has granted premarket approval of the company’s ThinPrep Genesis processor for cytology processing and specimen transfer for downstream applications.
Read More »Bio-Rad launches InteliQ Diabetes Control
May 21, 2021–Bio-Rad Laboratories launched its InteliQ Diabetes Control, the 10th product offered in the InteliQ format.
Read More »Beckman launches fully quantitative COVID-19 IgG test
May 20, 2021—Beckman Coulter launched its Access SARS-CoV-2 IgG (1st IS), a fully quantitative lab-based immunoglobulin G serology test that measures the quantity of antibodies against the virus that causes COVID-19.
Read More »FDA greenlights Medbaye Clirra application
May 19, 2021—Medical software company Medbaye announced the availability of its Clirra application after it received clearance under the FDA's guidelines for device software functions and mobile medical applications.
Read More »QIAreach Anti-SARS-CoV-2 Total Test receives EUA
May 17, 2021—Qiagen received emergency use authorization for its QIAreach Anti-SARS-CoV-2 Total Test, a digital assay to detect total SARS-CoV-2 antibodies (IgA, IgG, IgM).
Read More »FDA clears GSD’s B. burgdorferi VlsE-OspC IgG/IgM assay
May 14, 2021—Gold Standard Diagnostics announced the availability of its FDA-cleared B. burgdorferi VlsE-OspC IgG/IgM recombinant ELISA screen.
Read More »Beckman Coulter launches its DxA 5000 Fit for mid-size labs
May 4, 2021—Beckman Coulter launched its DxA 5000 Fit, a workflow automation solution for medium-size labs that run fewer than 5,000 tests a day.
Read More »Orchard Software acquires Corwen
May 3, 2021—Orchard Software has acquired Corwen, LLC, to expand molecular testing LIS support.
Read More »FDA approves Roche MMR test as a companion diagnostic
April 23, 2021—Roche announced FDA approval of the Ventana MMR RxDx Panel for advanced or recurrent endometrial cancer patients.
Read More »Bio-Rad launches SARS-CoV-2 variant RT-PCR assays
April 21, 2021—Bio-Rad Laboratories launched SARS-CoV-2 Variant RT-PCR Assays for research use only.
Read More »FDA authorizes two Quidel SARS-CoV-2 tests
April 16, 2021—Quidel received FDA emergency use authorization allowing the company to market its QuickVue At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days, with at least 24 hours, but no more than 36 hours, between tests.
Read More »FDA expands EUA for TaqPath COVID-19 combo kit
April 14, 2021–Thermo Fisher Scientific announced the FDA has expanded emergency use authorization for the Applied Biosystems TaqPath COVID-19 Combo Kit to include the high-throughput Thermo Fisher Scientific Amplitude solution.
Read More »Promega launches XpressAmp Direct Amplification Reagents
April 13, 2021—Promega Corp. released its XpressAmp Direct Amplification Reagents.
Read More »Herbek Hustle Memorial 5K
Gene Herbek, MD, FCAP, was a respected pathologist at Methodist Hospital for nearly 20 years as well as a beloved husband, father, and friend. His passing in 2020 was a tremendous loss for his loved ones, patients, and colleagues. The Women’s Methodist Hospital pathology department, Methodist Hospital, and the CAP Foundation together with Dr. Herbek's family present the Herbek Hustle 5K Memorial Fun Run on June 19.
Read More »DiaSorin acquires Luminex for $1.8 billion
April 12, 2021—DiaSorin has signed a definitive merger agreement to acquire Luminex for a total equity value of about $1.8 billion.
Read More »Hologic to acquire Mobidiag
April 9, 2021—Hologic has signed a definitive agreement to acquire Mobidiag Oy, a privately held Finnish-French developer of molecular diagnostic tests and instrumentation, for about $795 million.
Read More »Roche launches Elecsys Epstein-Barr virus immunoassay panel
April 8, 2021—Roche’s Elecsys EBV panel has launched in countries accepting the CE mark
Read More »FDA authorizes Beckman’s IgG antibody for SARS-CoV-2
April 7, 2021—Beckman Coulter’s Access SARS-CoV-2 IgG II antibody assay received U.S. emergency use authorization from the FDA.
Read More »LigoLab software for supporting school surveillance testing
April 6, 2021—LigoLab announced the availability of its direct-to-consumer platform TestDirectly, for clinical laboratories to use to support COVID-19 school surveillance testing.
Read More »FDA authorizes BD combination COVID-19, flu rapid antigen test
April 5, 2021—BD announced that the FDA granted emergency use authorization for its rapid antigen test that can detect SARS-CoV-2, influenza A, and influenza B in a single test.
Read More »Diazyme obtains CE-IVD mark for SARS-CoV-2 neutralizing antibody test
April 2, 2021—Diazyme Laboratories obtained CE-IVD marking for its SARS-CoV-2 neutralizing antibody test, a high-throughput chemiluminescent immunoassay.
Read More »DiaSorin gets EUA for Liaison SARS-CoV-2 Ag
April 1, 2021—DiaSorin received emergency use authorization from the FDA for its Liaison SARS-CoV-2 Ag.
Read More »Qiagen gets EUA for NeuMoDx COVID-19 multiplex test
March 31, 2021— Qiagen announced FDA emergency use authorization for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, to help identify people suspected of respiratory viral infection consistent with COVID-19.
Read More »Agena launches panel for SARS-CoV-2 variants
March 29, 2021—Agena Bioscience launched its MassArray SARS-CoV-2 Variant Panel (RUO) for the detection of key SARS-CoV-2 virus strains.
Read More »Diazyme semiquantitative SARS-CoV-2 IgG test gets EUA
March 26, 2021—Diazyme received FDA emergency use authorization for its Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test, which runs on the DZ-Lite 3000 Plus chemiluminescence analyzer.
Read More »Roche launches SARS-CoV-2 variant test
March 25, 2021—Roche launched the Cobas SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the U.K. (B.1.1.7), South Africa (B.1.351), and Brazil (P.1).
Read More »Thermo Fisher’s customizable SARS-CoV-2 mutation panel
March 24, 2021—Thermo Fisher Scientific launched its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel, a customizable menu of 22 verified real-time PCR assays for identification of SARS-CoV-2 mutations.
Read More »FDA approves Ventana ALK (D5F3) CDx assay with Lobrena
March 23, 2021—Roche announced FDA approval of the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with Pfizer’s drug Lorbrena (lorlatinib).
Read More »QIAsphere cloud-based platform launched with QIAstat-Dx
March 22, 2021—Qiagen launched its QIAsphere cloud-based platform that will allow labs and QIAstat-Dx users to monitor tests and instrument status remotely 24 hours a day, seven days a week.
Read More »Bio SB launches antibodies for SARS-CoV-2
March 19, 2021—Bio SB has developed a new panel of SARS-CoV-2 antibodies to identify the COVID-19 virus, its receptors, and cytokines by immunohistochemistry and immunofluorescence on formalin-fixed, paraffin-embedded biopsies.
Read More »Mikroscan releases upgraded 20-slide autoloader
March 18, 2021—Mikroscan Technologies announced its upgraded 5-20 series line of telemicroscopy and digital pathology systems, featuring a 20-slide autoloader.
Read More »Oxford Immunotec submits EUA for T-SPOT.COVID test
March 17, 2021—Oxford Immunotec has released the T-SPOT.COVID test, a CE-marked ELISpot-based test intended for qualitative detection of T-cell immune response to SARS-CoV-2 in human whole blood.
Read More »Roche to acquire GenMark Diagnostics
March 16, 2021—Roche and GenMark Diagnostics have entered into a definitive merger agreement for Roche to acquire GenMark for about $1.8 billion on a fully diluted basis.
Read More »FDA authorizes Cue Health’s OTC COVID-19 test
March 15, 2021—Cue Health has received FDA emergency use authorization for over-the-counter sale of its COVID-19 test.
Read More »Alinity m Resp-4-Plex molecular assay gets EUA
March 11, 2021—The FDA granted emergency use authorization for Abbott’s Alinity m Resp-4-Plex molecular assay, which detects and differentiates SARS-CoV-2, influenza A and B, and respiratory syncytial virus in one test.
Read More »Qiagen, Inovio expand collaboration to develop NGS CDx
March 10, 2021—Qiagen and Inovio Pharmaceuticals announced an extension of their partnership with a new agreement to develop liquid-biopsy-based companion diagnostic products based on next-generation sequencing technology to complement Inovio’s therapies.
Read More »Bio-Techne to acquire Asuragen
March 9, 2021—Bio-Techne Corp. has reached an agreement to acquire Asuragen for an initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones.
Read More »Bio-Rad introduces Bio-Plex IgG SARS-CoV-2 serology assays
March 5, 2021—Bio-Rad Laboratories launched the Bio-Plex Pro Human IgG SARS-CoV-2 N/RBD/S1/S2 4-Plex Panel, a qualitative multiplex immunoassay kit that detects IgG antibodies against four SARS-CoV-2 antigens in less than three hours.
Read More »Qiagen launches QIAcube Connect MDx
March 4, 2021—Qiagen announced the global launch of the CE-IVD-marked QIAcube Connect MDx, a flexible platform for automated sample processing available now to molecular diagnostic laboratories in the U.S., Canada, the European Union, and other markets worldwide.
Read More »Agilent to acquire Resolution Bioscience
March 3, 2021—Agilent Technologies announced it has entered into a definitive agreement to acquire Resolution Bioscience, a next-generation-sequencing–based technology company.
Read More »Seegene submits SARS-CoV-2, flu A/B, RSV assay for EUA
March 2, 2021—Seegene announced it has submitted its Allplex SARS-CoV-2/FluA/FluB/RSV Assay to the FDA for emergency use authorization.
Read More »Adaptive Biotechnologies launches T-Detect COVID test
March 1, 2021—Adaptive Biotechnologies Corp. launched its T-Detect COVID, a clinical T-cell–based test to confirm recent or prior COVID-19 infection.
Read More »Hologic completes acquisition of Biotheranostics
Feb. 26, 2021–Hologic has completed its acquisition of Biotheranostics for about $230 million. Biotheranostics develops and markets Breast Cancer Index and CancerType ID, two highly differentiated molecular diagnostic tests for breast and metastatic cancers.
Read More »Siemens lab-based CoV2Ag test for high-throughput analyzers
Feb. 25, 2021–Siemens Healthineers announced the company's laboratory-based SARS-CoV-2 Antigen Assay obtained the CE mark; the test runs on the Atellica IM analyzer, which has the capacity to run 440 tests per hour, and the Advia Centaur XP and XPT immunoassay systems.
Read More »Bio-Rad Reliance RT-PCR COVID assays granted EUA
Feb. 23, 2021–Bio-Rad Laboratories announced that its Reliance SARS-CoV-2/FluA/FluB RT-PCR and Reliance SARS-CoV-2 RT-PCR assay kits were granted emergency use authorization by the FDA.
Read More »BD gets EUA, CE mark for combo SARS-CoV-2, flu A+B test
Feb. 19, 2021–BD announced FDA emergency use authorization for a molecular diagnostic test for SARS-CoV-2 and influenza A and B that can return results in two to three hours. The test also has been CE marked to the IVD directive.
Read More »Visby POC COVID-19 PCR test gets CLIA waiver
Feb. 17, 2021–Visby Medical announced FDA authorization of the company’s rapid PCR COVID-19 test for use at the point of care by organizations with a CLIA certificate of waiver.
Read More »Bio-Rad enhances InteliQ QC line
Feb. 12, 2021–Bio-Rad Laboratories has enhanced its InteliQ liquid quality controls product line.
Read More »FDA clears Cobas BKV test for urine samples
Feb. 12, 2021–Roche announced FDA 510(k) clearance of stabilized urine samples to be used with the Cobas BKV test on the Cobas 6800/8800 systems.
Read More »BioDiscovery releases upgrade to NxClinical software system
Feb. 11, 2021–BioDiscovery has released NxClinical 6.0, the company’s fifth major upgrade to its software for integrated analysis of copy number, sequence variants, and allelic changes obtained from multiple technologies.
Read More »Seegene rolls out COVID-19 mutant identification test
Feb. 9, 2021–Seegene announced it has developed the first COVID-19 diagnostic variant test capable of screening COVID-19 and identifying multiple mutant variations in a single reaction.
Read More »LGC acquires Technopath Clinical Diagnostics
Feb. 5, 2021–LGC announced its acquisition of Technopath Clinical Diagnostics, expanding LGC’s position in the clinical diagnostics QC market.
Read More »Sarstedt Microvette automated processing tubes
Feb. 3, 2021–Sarstedt introduced the Microvette APT for capillary blood collection.
Read More »Beckman launches tabletop DxH 560 AL hematology analyzer
Jan. 29, 2021—Beckman Coulter launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories.
Read More »Tecan launches automated whole blood processing system
Jan. 22, 2021—Tecan has launched the Fluent Mix and Pierce Workstation to provide end-to-end automation for whole blood pipetting in clinical environments.
Read More »PerkinElmer assay gets EUA for asymptomatic testing
Jan. 15, 2021–PerkinElmer announced that its PerkinElmer New Coronavirus Nucleic Acid Detection Kit received emergency use authorization from the FDA to test individuals without symptoms or other reasons to suspect COVID-19 infection.
Read More »DiaSorin gets BARDA funding for 510(k) clearance
Jan. 14, 2021–DiaSorin Molecular received additional federal funding from the Biomedical Advanced Research and Development Authority for the validation and submission of the Simplexa COVID-19 Direct kit and the Simplexa COVID-19 & Flu A/B Direct kit for FDA 510(k) clearance.
Read More »Sanger Institute’s COSMIC database licensed via Qiagen
Jan. 13, 2021–Qiagen announced that it now retains the exclusive rights to license and distribute the COSMIC database from the Wellcome Sanger Institute for commercial use, effective Jan. 1.
Read More »Biocare unveils Oncore Pro IVD platform for IHC, ISH
Jan. 11, 2021–Biocare Medical released its Oncore Pro fully automated slide staining system, a compact, benchtop instrument that performs immunohistochemistry and in situ hybridization procedures on formalin-fixed, paraffin-embedded tissues.
Read More »Siemens IL-6 test receives emergency use authorization
Jan. 7, 2021–The FDA has issued an emergency use authorization for Siemens Healthineers’ laboratory-based IL-6 assay to measure the presence of interleukin-6 in human serum or plasma.
Read More »UnitedHealth to acquire Change Healthcare
Jan. 6, 2021—Optum, a part of UnitedHealth Group, and Change Healthcare have agreed to combine. Change Healthcare will join with the OptumInsight business to provide software and data analytics, technology-enabled services and research, and advisory and revenue cycle management offerings.
Read More »Quidel gets EUA for Solana SARS molecular test
Dec. 29, 2020—Quidel received emergency use authorization from the FDA to market its Solana SARS-CoV-2 assay
Read More »CompuGroup Medical purchases eMDs
Dec. 28, 2020—CompuGroup Medical has acquired eMDs, a provider of ambulatory information systems and outsourcing services for medical accounting, for approximately $240 million.
Read More »FDA approves new indication for Tagrisso
Dec. 23, 2020—AstraZeneca’s Tagrisso (osimertinib) has been FDA approved for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after tumor resection with curative intent.
Read More »Quidel gets EUA for QuickVue SARS rapid antigen test
Dec. 22, 2020 —Quidel announced it received emergency use authorization from the FDA to market its QuickVue SARS Antigen test, a point-of-care assay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares swab specimens from people who are suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms.
Read More »Reduced TAT for Vivalytic SARS-CoV-2 positive samples
Dec. 21, 2020—Randox announced that its improved software for the Vivalytic analysis device enables its CE-marked Vivalytic SARS-CoV-2 rapid coronavirus test to deliver results for positive samples in less than 30 minutes.
Read More »Beckman launches $4, high-throughput COVID-19 antigen test
Dec. 18, 2020—Beckman Coulter launched the Access SARS-CoV-2 Antigen assay, a high-throughput COVID-19 test available in the U.S., priced at $4 to health care providers, including public and private institutions, governments, and nonprofits.
Read More »FDA authorizes first OTC at-home test for COVID-19
Dec. 16, 2020—The FDA issued an emergency use authorization for the first over-the-counter, at-home diagnostic test for COVID-19.
Read More »Roche launches CE-marked Cobas PIK3CA Mutation Test
Dec. 15, 2020—Roche launched the Cobas PIK3CA Mutation Test CE-IVD for patients with advanced or metastatic breast cancer in countries accepting the CE mark.
Read More »Siemens Epoc NXS Host gets CE mark, FDA clearance
Dec. 11, 2020—Siemens Healthineers announced it received the CE mark and FDA 510(k) clearance for the Epoc NXS Host mobile computer
Read More »FDA authorizes direct-to-consumer COVID-19 test system
Dec. 10, 2020—The FDA authorized the first COVID-19 direct-to-consumer test system—LabCorp’s Pixel COVID-19 Test Home Collection Kit, for use by any person 18 years and older without a prescription.
Read More »COVID-19, flu test authorized for home-collected samples
Dec. 7, 2020—The FDA authorized the first diagnostic test for at-home collection of patient samples to detect COVID-19 and influenza A and B.
Read More »Roche receives EUA for Elecsys Anti-SARS-CoV-2 S test
Dec. 2, 2020—Roche announced that its Elecsys Anti-SARS-CoV-2 S antibody test has received emergency use authorization from the FDA.
Read More »Bio-Rad launches SARS-CoV-2, flu, RSV run controls
Dec. 1, 2020—Bio-Rad Laboratories launched its SARS-CoV-2, Flu, RSV positive and negative run controls.
Read More »COVID-19, flu, RSV test available from ARUP
Nov. 24, 2020–ARUP Laboratories announced the availability of a combined test to detect and differentiate COVID-19, influenza, and/or respiratory syncytial virus in individuals with respiratory symptoms consistent with COVID-19.
Read More »Orchard Software adds AWS cloud services solution
Nov. 23, 2020—Orchard Software is now working with Amazon Web Services cloud platform.
Read More »Sysmex adds FDA-cleared CellaVision DC-1 to portfolio
Nov. 20, 2020—Sysmex America has added the FDA 510(k)-cleared CellaVision DC-1 to its portfolio of CellaVision products for low-volume hematology labs.
Read More »FDA authorizes at-home COVID-19 test
Nov. 18, 2020—The FDA issued an emergency use authorization to Lucira Health for its COVID-19 All-In-One Test Kit, the first COVID-19 diagnostic test for self-testing at home and that provides rapid results.
Read More »Qiagen launches NeuMoDx multiplex test
Nov. 17, 2020—Qiagen announced the European launch of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage test, which aims to help health care professionals identify and differentiate between patients with common seasonal respiratory infections and COVID-19.
Read More »Nova Biomedical launches blood glucose reference analyzer
Nov. 13, 2020—Nova Biomedical announced the availability of Nova Primary, a rapid blood glucose laboratory analyzer.
Read More »TechLab partners with New River Health District
Nov. 9, 2020—TechLab has partnered with New River Valley COVID-19 Task Force to expand future COVID-19 testing capacity.
Read More »OGT expands NGS cancer panel offering
Nov. 6, 2020—Oxford Gene Technology has expanded its SureSeq range of next-generation sequencing panels to include a comprehensive myeloid panel and a breast and ovarian cancer panel that incorporate copy number variation detection.
Read More »PerkinElmer to acquire Horizon, gets EUA for sample pooling
Nov. 4, 2020—PerkinElmer and Horizon Discovery have reached an agreement in which PerkinElmer will acquire Horizon for about $383 million.
Read More »Cobas EGFR Mutation Test v2 gets expanded approval
Oct. 30, 2020—Roche announced FDA approval of expanded claims for the Cobas EGFR Mutation Test v2 as a companion diagnostic for a broad group of therapies in the treatment of non-small cell lung cancer.
Read More »Randox whole pathogen controls for respiratory disease
Oct. 29, 2020—Randox Laboratories has unveiled its Qnostics Multiplex Respiratory Pathogen Controls for respiratory diseases, including for SARS-CoV-2, influenza A and B, and respiratory syncytial virus.
Read More »Independent, third-party blood bank validations
BC Solutions explains why third-party blood bank validations might be right for your laboratory in this Q&A. Congratulations! Your lab is finally installing or upgrading your new blood establishment computer system (BECS). Read more.
Read More »Agena granted EUA for high-throughput SARS-CoV-2 panel
Oct. 28, 2020—Agena Bioscience’s MassArray SARS-CoV-2 Panel for qualitative detection of the SARS-CoV-2 coronavirus has been granted emergency use authorization from the FDA.
Read More »Dark Daily report on developing a COVID-19 testing program
Dark Daily has published How to Develop a COVID-19 Employee Testing Program: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues for Clinical Laboratories and Employers. For more information and to download the report, click here.
Read More »FDA approves first treatment for COVID-19
Oct. 26, 2020—The FDA approved Gilead Sciences’ antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.
Read More »Visby Medical’s personal PCR device for COVID-19 testing gets EUA
Oct. 23, 2020—The FDA has issued an emergency use authorization for Visby Medical’s single-use personal PCR device, a rapid test for detecting COVID-19.
Read More »Lenco Lab using CGM LIS in COVID-19 testing program
Oct. 22, 2020—CompuGroup Medical recently reported that it contributed to Lenco Diagnostic Laboratory launching its COVID-19 testing program in Brooklyn, NY.
Read More »FDA issues EUA for saline oral rinse COVID test
Oct. 15, 2020—OralDNA Labs announced that the FDA has issued an amended emergency use authorization for the OraRisk COVID-19 RT-PCR test, allowing testing from a saline oral rinse collection.
Read More »Beckman’s SARS-CoV-2 IgM antibody test gets EUA
Oct. 12, 2020—Beckman Coulter announced its Access SARS-CoV-2 immunoglobulin M assay has received emergency use authorization from the FDA.
Read More »GenMark ePlex Respiratory Pathogen Panel 2 receives EUA
Oct. 9, 2020—GenMark Diagnostics received FDA emergency use authorization for its ePlex Respiratory Pathogen Panel 2.
Read More »Aptima SARS-CoV-2 assay to include testing of asymptomatic people
Oct. 7, 2020—Hologic’s Aptima SARS-CoV-2 assay, which initially received emergency use authorization from the FDA in May, is now authorized for testing people without symptoms or other reasons to suspect COVID-19 infection.
Read More »CompuGroup Medical hosts virtual user conference
Oct. 6, 2020—CompuGroup Medical US will hold its annual CGM LABDAQ User Conference virtually, starting Oct. 6.
Read More »Beckman Coulter Access IL-6 test gets EUA
Oct. 6, 2020—Beckman Coulter has received emergency use authorization for its Access Interleukin-6 assay from the FDA.
Read More »Cepheid SARS-CoV-2, flu A/B, RSV test gets EUA
Oct. 5, 2020—Cepheid received emergency use authorization from the FDA for its Xpert Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses that cause COVID-19, flu A, flu B, and RSV infections from a single patient sample.
Read More »Technopath introduces QC data management solution
Oct. 2, 2020—Technopath Clinical Diagnostics introduced IAMQC Infinity for the management of overall quality control and proficiency testing.
Read More »FDA approves liquid biopsy NGS CDx
Oct. 1, 2020—The FDA approved the Guardant360 CDx assay (Guardant Health), a liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in a deadly form of metastatic non-small cell lung cancer.
Read More »Siemens, CDC to develop process to standardize SARS-CoV-2 assays
Sept. 29, 2020—Siemens Healthineers will collaborate with the Centers for Disease Control and Prevention and the Joint Research Centre of the European Commission on a research project to develop a novel process for standardizing SARS-CoV-2 assays.
Read More »FDA issues EUA for Yale’s SalivaDirect
Sept. 28, 2020—The FDA issued an emergency use authorization to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection, the agency says.
Read More »FDA approves expanded use of CINtec Plus Cytology
Sept. 25, 2020—Roche announced FDA approval for the expanded use of CINtec Plus Cytology, a triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus.
Read More »Accumen releases EUA COVID-19 saliva testing kits
Sept. 24, 2020—Accumen announced a partnership with medical equipment manufacturer Spectrum Solutions to provide saliva testing kits for detecting COVID-19.
Read More »ARUP shares formula for transport media
Sept. 23, 2020—ARUP Laboratories’ formula for ARUP Transport Media is now available to other laboratories.
Read More »Qiagen fully acquires NeuMoDx Molecular
Sept. 22, 2020—Qiagen has acquired the remaining 80.1 percent of NeuMoDx Molecular for $248 million in cash.
Read More »ARUP offers COVID-19 saliva testing
Sept. 16, 2020—ARUP Laboratories announced it now offers COVID-19 testing using saliva specimens.
Read More »Magnolia Medical launches Mission to Zero
Sept. 14, 2020―Magnolia Medical Technologies launched Mission to Zero, to bring greater awareness to the patient safety and antibiotic-associated risks caused by false-positive diagnostic test results for sepsis.
Read More »Roche BKV test FDA cleared on Cobas 6800/8800 systems
Sept. 9, 2020—Roche received FDA 510(k) clearance for the Cobas BKV test on the Cobas 6800 and 8800 systems.
Read More »FDA clears Simplexa Flu A/B & RSV Direct Gen II assay
Sept. 8, 2020—DiaSorin Molecular received FDA clearance for its Simplexa Flu A/B & RSV Direct Gen II kit.
Read More »Roche receives EUA for Cobas SARS-CoV-2 & Influenza A/B test
Sept. 4, 2020—Roche announced that the Cobas SARS-CoV-2 & Influenza A/B Test for use on the Cobas 6800/8800 systems has received emergency use authorization from the FDA.
Read More »Roche HIV 1/2 qualitative test approved on Cobas 6800/8800
Sept. 1, 2020—Roche announced FDA approval for the Cobas HIV-1/HIV-2 Qualitative test for use on the fully automated Cobas 6800/8800 systems in the United States.
Read More »Abbott’s BinaxNow 15-minute COVID-19 antigen test gets EUA
Aug. 27, 2020—The FDA has issued emergency use authorization for Abbott’s BinaxNOW COVID-19 Ag Card rapid test for the detection of COVID-19 infection.
Read More »Beckman Coulter launches SARS-CoV-2 IgM antibody test
Aug. 26, 2020—Beckman Coulter launched its Access SARS-CoV-2 Immunoglobulin M assay.
Read More »Qiagen expands coronavirus NGS, software solutions
Aug. 25, 2020—Qiagen has launched the QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing of the novel coronavirus genome and integrated analysis and interpretation workflows for insights into the evolution and spread of the virus.
Read More »Diazyme gets EUA for COVID-19 antibody test
Aug. 24, 2020—Diazyme Laboratories announced receiving FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test.
Read More »Adaptive gets expanded FDA clearance for ClonoSEQ assay
Aug. 20, 2020—Adaptive Biotechnologies received FDA clearance for its ClonoSEQ assay to detect and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.
Read More »Qiagen web series on biomarker profiling from FFPE samples
Aug. 18, 2020—Qiagen is offering a four-part web seminar series in which the latest tips and tricks for successful biomarker profiling from FFPE samples will be discussed.
Read More »LigoLab LIS and RCM operating platform
Aug. 17, 2020—LigoLab Information Systems offers a collection model that combines laboratory information systems and revenue cycle management workflows.
Read More »Vidas SARS-COV-2 antibody serology tests receive EUA
Aug. 14, 2020—BioMérieux received emergency use authorization by the U.S. Food and Drug Administration for its Vidas SARS-COV-2 IgM and Vidas SARS-COV-2 IgG serology tests.
Read More »Siemens gets EUA for semiquantitative antibody test
Aug. 12, 2020—Siemens Healthineers received FDA emergency use authorization for the SARS-CoV-2 IgG antibody test. It is the.first antibody test authorized with a semiquantitative detection claim.
Read More »Sysmex to distribute, service Siemens Clinitek Novus
Aug. 11, 2020–Sysmex America announced an exclusive agreement with Siemens Healthineers that grants North American rights to distribute and service Siemens Clinitek Novus Automated Urine Analyzer for hospital and reference laboratory use.
Read More »Roche launches Cobas Prime Pre-analytical System
Aug. 6, 2020—Roche launched its Cobas Prime Pre-analytical System, designed to automate common preanalytic steps performed in a molecular diagnostics laboratory, including vortexing, decapping, aliquoting, barcode labeling, reagent addition, and heating.
Read More »Diazyme, Maccura launch COVID-19 test
Aug. 5, 2020—Diazyme announced a partnership with Maccura Biotechnology (USA) and launched an FDA EUA approved SARS-COV-2 RT-PCR diagnostics test.
Read More »Sysmex America releases Caresphere Workflow Solution
Aug. 4, 2020—Sysmex America announced the availability of its clinical software application, Caresphere Workflow Solution, a Hitrust CSF–certified, cloud-based software solution that is designed to enable sophisticated test result workflow optimization for laboratories to meet increasing demands, streamline decision-making, and reduce risk.
Read More »Alpha-Tec launches SARS-CoV-2, HPV controls
July 31, 2020—Alpha-Tec Systems has partnered with Microbix to provide whole-genome molecular REDx control products
Read More »FDA approves Ventana HER2 Dual ISH test as CDx
July 30, 2020—Roche announced U.S. Food and Drug Administration approval of the Ventana HER2 Dual ISH DNA Probe Cocktail assay
Read More »Bio SB launches Fast Mohs PolyDetector Plus for IHC
July 29, 2020—Bio SB launched its Fast Mohs PolyDetector Plus Detection System, a highly sensitive nonbiotin monovalent Fab micropolymer immunohistochemistry detection system
Read More »FDA approves expanded version of BD HPV assay
July 28, 2020—Becton Dickinson received approval for a premarket approval supplement from the FDA for an expanded version of its BD Onclarity HPV Assay.
Read More »OGT’s CytoSure v3 improves reporting rate
July 27, 2020—In a recent NPJ Genomic Medicine paper, Oxford Gene Technology’s CytoSure Constitutional v3 array design has been shown to significantly improve reporting rate and been proven as a powerful tool for detection of small pathogenic intragenic deletions and duplications in developmental disorder research.
Read More »Diaceutics partners with Targos, HistoCyte Labs on dx network
July 24, 2020—Diaceutics announced two partnerships, with Targos Molecular Pathology and HistoCyte Laboratories, on its DXRX platform. an end-to-end solution for the development and commercialization of precision medicine diagnostics.
Read More »Luminex receives EUA for COVID-19 antibody test
July 23, 2020—Luminex Corp. announced that the FDA issued an emergency use authorization for the company’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay.
Read More »Sofia SARS Antigen FIA receives CE mark
July 22, 2020—The Sofia SARS Antigen Fluorescent Immunoassay received the CE mark for use with the Sofia and Sofia 2 instruments.
Read More »GenMark launches ePlex Respiratory Pathogen Panel 2
July 21, 2020—GenMark Diagnostics announced that its ePlex Respiratory Pathogen 2 Panel is available for U.S. commercial distribution and clinical use.
Read More »FDA issues first EUA for sample pooling in dx testing
July 20, 2020—The FDA reissued on July 18 an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation.
Read More »Roche, Summit collaborate to provide personalized cancer care
July 14, 2020—Roche and Summit Cancer Centers will collaborate to explore the use of clinical decision support tools and artificial intelligence–type approaches to the management of patient health information.
Read More »Diazyme receives FDA EUA for COVID-19 antibody test
July 10, 2020—Diazyme Laboratories received FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.
Read More »Simplexa Flu A/B & RSV Direct Gen II assay gets CE mark
July 9, 2020—DiaSorin Molecular announced that its Simplexa Flu A/B & RSV Direct Gen II kit has received the CE mark.
Read More »FDA approves Cobas EZH2 Mutation Test as CDx
July 7, 2020—The Food and Drug Administration approved the Roche Cobas EZH2 Mutation Test as a companion diagnostic for Tazverik (tazemetostat), developed by Epizyme.
Read More »BD launches point-of-care SARS-CoV-2 antigen test
July 7, 2020—Becton Dickinson announced that the FDA granted emergency use authorization to the BD Veritor Plus System for Rapid Detection of SARS-CoV-2 Assay, a rapid, point-of-care, diagnostic test for use with the BD Veritor Plus System.
Read More »Luminex submits EUA request for COVID-19 antibody test
July 6, 2020—Luminex Corp. has submitted an emergency use authorization request to the FDA for its xMAP SARS-CoV-2 Multi-Antigen IgG assay.
Read More »Beckman’s Access SARS-CoV-2 IgG receives EUA
July 2, 2020—Beckman Coulter has received FDA emergency use authorization for its Access SARS-CoV-2 IgG assay.
Read More »Roche’s Elecsys IL-6 test receives FDA EUA
July 1, 2020—Roche announced that the FDA has issued an emergency use authorization for the Elecsys IL-6 test
Read More »Invitae to acquire ArcherDX for $1.4 billion
June 30, 2020—Invitae and ArcherDX have entered into a definitive agreement under which the two companies will combine to create a cancer genetics and precision oncology company.
Read More »Sysmex America launches XF-1600 automated flow cytometer
June 26, 2020—Sysmex America announced the availability of its XF-1600 automated flow cytometer.
Read More »Simplexa Congenital CMV Direct kit gets CE mark
June 24, 2020—DiaSorin Molecular announced it has received the CE mark for its Simplexa Congenital CMV Direct kit.
Read More »Randox unveils cytokine tests
June 22, 2020—Randox Laboratories has unveiled cytokine testing for COVID-19 risk stratification and treatment monitoring.
Read More »Illumina receives EUA for sequencing-based COVID-19 dx
June 12, 2020—Illumina announced that the FDA issued an emergency use authorization for the Illumina COVIDSeq test, a high-throughput, sequencing-based, in vitro diagnostic workflow enabling the detection of SARS-CoV-2.
Read More »Randox ToRCH quality controls get CE mark
June 10, 2020—Randox Laboratories ToRCH quality controls for infectious disease testing in newborns have been granted the CE mark.
Read More »NeuMoDx introduces high-vol nucleic acid extraction capability
June 8, 2020—NeuMoDx Molecular released software that introduces “extraction only” capabilities among other enhancements.
Read More »FDA approves Opdivo + Yervoy, chemo for metastatic NSCLC
June 5, 2020—The Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, BMS)
Read More »Qiagen introduces novel solutions in oncology
June 4, 2020—Qiagen announced the launch of novel solutions designed to enable faster, better analysis of genomic variations in cancer
Read More »Siemens SARS-CoV-2 total antibody test receives EUA
June 3, 2020—Siemens Healthineers announced the FDA has issued an emergency use authorization for its laboratory-based total antibody test
Read More »FDA clears LVDS with BioMérieux culture systems
May 29, 2020—BioMérieux’s BACT/Alert BPA and BPN culture bottles received 510(k) clearance from the FDA for Large Volume Delayed Sampling of leukocyte-reduced apheresis platelets and leukocyte-reduced whole blood platelet concentrates with BACT/Alert 3D and Virtuo systems.
Read More »Enzo launches SARS-CoV-2 IgG ELISA kit
May 28, 2020—Enzo Biochem announced it is offering a SARS-CoV-2 IgG ELISA assay kit for serological detection of IgG antibodies against the novel coronavirus under the FDA’s emergency use authorization.
Read More »Siemens COVID-19 total antibody test, molecular test
May 27, 2020—Siemens Healthineers announced it is shipping worldwide its CE-marked, laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood.
Read More »Bio-Rad RT-PCR system available for COVID-19 testing
May 26, 2020—Bio-Rad Laboratories announced that its CFX96 Dx Real-Time PCR System has been listed with the FDA for IVD testing and may be used to help in the diagnosis of COVID-19.
Read More »Aalto recombinant spike proteins for COVID dx testing
May 21, 2020—Aalto Bio Reagents announced the availability of its range of recombinant SARS-CoV-2 spike (S) proteins for diagnostic test manufacturers, vaccine developers, and researchers.
Read More »Oxford Immunotec releases T-Spot Discovery SARS-CoV-2 kit
May 20, 2020—Oxford Immunotec announced the release of the research use only T-Spot Discovery SARS-CoV-2 test kit.
Read More »EUA, CE mark for Quidel Lyra Direct SARS-CoV-2 Assay
May 20, 2020—Quidel announced it has received emergency use authorization for the Lyra Direct SARS-CoV-2 Assay from the Food and Drug Administration to allow direct sample processing.
Read More »Ortho’s COVID-19 IgG antibody test receives CE mark
May 19, 2020—Ortho Clinical Diagnostics announced its second COVID-19 antibody test, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test, received the CE mark. The test offers 100 percent specificity.
Read More »Agilent PD-L1 assay FDA approved as CDx
May 19, 2020—Agilent Technologies announced that the Food and Drug Administration has approved the
Read More »Hologic granted EUA for second molecular test for COVID-19
May 15, 2020—Hologic announced it has received emergency use authorization from the FDA for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.
Read More »ARUP offers second COVID-19 antibody test
May 14, 2020—ARUP Laboratories announced that it is making a second COVID-19 IgG antibody test available nationwide.
Read More »Ortho’s COVID-19 total antibody test receives CE mark
May 13, 2020—Ortho Clinical Diagnostics announced its COVID-19 total antibody test received the CE mark.
Read More »Abbott gets EUA for COVID-19 test on Alinity i
May 12, 2020—Abbott announced that the FDA issued EUA for the company's SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.
Read More »Quidel receives EUA for rapid antigen COVID-19 assay
May 11, 2020—Quidel announced it has received emergency use authorization from the FDA to market its Sofia 2 SARS Antigen FIA
Read More »FDA provides EUA to PerkinElmer for COVID-19 serological test
May 7, 2020—PerkinElmer announced that the FDA has provided emergency use authorization for Euroimmun’s Anti-SARS-CoV-2 ELISA (IgG) serology test.
Read More »Bio-Rad SARS-CoV-2 serology, ddPCR tests granted EUAs
May 6, 2020—Bio-Rad Laboratories announced it was granted FDA emergency use authorization for the company's SARS-CoV-2 Total Ab test, a blood-based immunoassay that
Read More »FDA grants Hardy Diagnostics EUA for COVID-19 antibody test
May 5, 2020—Hardy Diagnostics announced FDA EUA approval the Anti-SARS-CoV-2 Rapid Test.
Read More »FDA enforcement discretion now includes Aperio WebViewer
May 4, 2020—Leica Biosystems announced it has received additional notification from the FDA about its intention to exercise enforcement discretion when the Aperio WebViewer, a web-based viewing software within Aperio eSlide Manager
Read More »Roche’s COVID-19 antibody test receives EUA
May 4, 2020—Roche announced that the FDA has issued an emergency use authorization for its Elecsys Anti-SARS-CoV-2 antibody test.
Read More »Rheonix receives EUA for rapid molecular COVID-19 test
May 1, 2020—Rheonix announced it has received FDA emergency use authorization for the Rheonix COVID-19 MDx Assay.
Read More »Hologic to launch second assay for novel coronavirus
April 30, 2020—Hologic plans to launch an Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its Panther system, which provides initial results in about three hours and processes more than 1,000 coronavirus tests in a 24-hour period. The company expects to begin distributing next week a research use only version of its Aptima SARS-CoV-2 test to ...
Read More »Ortho launches second COVID-19 antibody test
April 27, 2020—Ortho Clinical Diagnostics announced the FDA granted emergency use authorization to its second COVID-19 antibody test, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test.
Read More »FDA approves Cobas HPV test for Cobas 6800/8800 systems
April 24, 2020—Roche announced FDA approval for the Cobas HPV test for use on the fully automated, high-throughput Cobas 6800/8800 systems.
Read More »ELITechGroup MDx distributes EUA kit
April 23, 2020—ELITechGroup MDx and its Korean partner, Osang Healthcare, announced that the FDA has issued emergency use authorization for its SARS-CoV-2 virus test for use in the United States.
Read More »Randox unveils molecular controls for SARS-CoV-2
April 23, 2020—Randox Laboratories has developed Randox Qnostics SARS-CoV-2 whole pathogen quality controls designed for laboratories managing COVID-19 testing to help ensure the accuracy and reliability of molecular assays used in the testing of suspected coronavirus samples.
Read More »FDA clears i-Stat CG4+, Chem8+
April 22, 2020—Abbott’s i-Stat CG4+ and Chem8+ cartridges have received FDA clearance.
Read More »ARUP Labs rolls out COVID-19 antibody testing
April 21, 2020—ARUP Laboratories will begin rolling out COVID-19 antibody testing nationwide by the end of this week.
Read More »Nova webinar on COVID-19 bedside glucose management
April 20, 2020—Nova Biomedical announced a webinar, titled “COVID-19 Bedside Glucose Management: Risk of Ascorbic Acid and Hematocrit Interference,” to help inform and support health care workers treating COVID-19 patients. Led by Charbel Abou-Diwan, PhD, director of Nova Biomedical’s medical and scientific affairs, the webinar examines the risk of inaccurate glucose meter results due to interference from ascorbic acid and ...
Read More »MedTest Dx FDA-approved quantitative test for G6PD
April 20, 2020—MedTest Dx announced the availability of its Pointe Scientific–branded assay for the highly sensitive quantification of G6PD in whole blood.
Read More »Roche develops serology test to detect COVID-19 antibodies
April 17, 2020—Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the SARS-CoV-2 virus.
Read More »Qiagen launches Therascreen BRAF V600E kit
April 16, 2020—Qiagen launched its novel Therascreen BRAF V600E RGQ PCR Kit following FDA approval of the kit as a companion diagnostic to the BRAF inhibitor Braftovi (encorafenib).
Read More »Asuragen develops Armored RNA Quant SARS-CoV-2 control
April 16, 2020—Asuragen has developed an Armored RNA Quant SARS-CoV-2 Control for use in developing assays in response to the COVID-19 pandemic.
Read More »Stat Profile Prime Plus FDA cleared for POC use
April 15, 2020—Nova Biomedical announced the FDA has cleared its Stat Profile Prime Plus critical care blood gas analyzer for point-of-care use. This clearance allows POC personnel to perform bedside critical care testing with results in one minute.
Read More »Abbott launches third COVID-19 test
April 15, 2020—Abbott announced today the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the IgG antibody that identifies if a person has had COVID-19.
Read More »BD gets second FDA EUA, CE mark for COVID-19 dx
April 13, 2020—BD announced that the FDA has granted emergency use authorization for a molecular diagnostic test for COVID-19 that can return results in two to three hours. The test also has been CE marked to the IVD directive.
Read More »OGT expands SureSeq NGS portfolio
April 13, 2020—Oxford Gene Technology has added detection capabilities for translocations and difficult-to-sequence partial tandem duplications in its MyPanel customizable SureSeq NGS panels.
Read More »Quansys Biosciences releases SARS-CoV-2 ELISA
April 10, 2020—Quansys Biosciences released its Q-Plex SARS-CoV-2 Human IgG (4-plex) enzyme-linked immunosorbent assay for the qualitative detection of SARS-CoV-2 reactive IgG class antibodies in human serum and plasma.
Read More »COVID-19 proficiency testing
April 10, 2020—The CAP has released a new proficiency testing program for the detection of SARS CoV-2 by nucleic acid amplification testing.
Read More »Aperio ImageScope DX Viewer approved for emergency use
April 9, 2020—Leica Biosystems has received notification from the FDA that its Aperio ImageScope DX Viewer with images acquired on the Aperio AT2 DX Scanner can be used for remote diagnosis under emergency use.
Read More »Nova Biomedical adds PT/INR test to Allegro
April 8, 2020—Nova Biomedical has added PT/INR testing to its Allegro capillary blood analyzer for point-of-care testing in primary care settings.
Read More »Ortho Clinical Diagnostics COVID-19 antibody test
April 6, 2020—Ortho Clinical Diagnostics is launching its SARS-CoV-2 antibody test, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack.
Read More »Cellex qSARS-CoV-2 IgG/IgM test gets EUA
April 3, 2020—Cellex has received FDA emergency use authorization for its Cellex qSARS-CoV-2 IgG/IgM Rapid Test.
Read More »BD, BioGX announce FDA EUA for COVID-19 dx
April 3, 2020—BD and BioGX announced that the FDA has granted emergency use authorization for a diagnostic test that will enable hospitals to screen for COVID-19 on site and get results in less than three hours.
Read More »Siemens releases test kit for SARS-CoV-2
April 3, 2020—Siemens Healthineers announced the availability of its molecular Fast Track Diagnostics SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus. Test kits are already being shipped within the European Union for research use only to expedite availability while the company continues to pursue emergency use assessment and listing from the World Health Organization for clinical use.
Read More »OncoLens offers free virtual tumor board platform
April 3, 2020—In response to COVID-19, OncoLens is offering the OncoLens virtual tumor board module at no cost, through the end of May 2020. The module enables cancer care teams to meet virtually, in real time, to discuss treatment options for their cancer patients on a secure, HIPAA-compliant platform.
Read More »BD, BioMedomics launch POC test to detect COVID-19
April 2, 2020—BD and BioMedomics, a privately held, North Carolina–based clinical diagnostics company, announced the release of a point-of-care test that can detect, in as few as 15 minutes, antibodies in blood to confirm current or past exposure to COVID-19.
Read More »NeuMoDx gets emergency use authorization for SARS-CoV2 test
April 2, 2020—NeuMoDx Molecular announced that the FDA has issued an emergency use authorization for the NeuMoDx SARS-CoV-2 Assay implemented on NeuMoDx molecular systems.
Read More »Beckman to develop tests to detect coronavirus antibodies
April 2, 2020—Beckman Coulter announced it is developing assays to identify IgM and IgG antibodies to SARS-CoV-2. The assays will be designed for use on any of the company’s high-throughput Access family of immunoassay systems.
Read More »FDA clears RapidPoint 500e Blood Gas Analyzer for critically ill
April 2, 2020—Siemens Healthineers announced that its RapidPoint 500e Blood Gas Analyzer has received clearance from the FDA. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room.
Read More »QIAstat-Dx test kit for SARS-CoV-2 gets EUA
April 1, 2020—Qiagen has received emergency use authorization from the FDA for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus.
Read More »Vivalytic test for detecting SARS-CoV-2
April 1, 2020—Randox Laboratories and Bosch Healthcare Solutionswill launch this month the Vivalytic Viral Respiratory Tract Infection Array, which can identify SARS-CoV-2 and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.
Read More »Abbott announces POC test for COVID-19
April 1, 2020—Abbott announced that the FDA has issued emergency use authorization for its molecular point-of-care test for the detection of novel coronavirus. The test delivers positive results in as few as five minutes and negative results in 13 minutes and runs on the company's ID Now platform.
Read More »Quidel’s Lyra SARS-CoV-2 gets expanded use authorization
March 31, 2020—Quidel’s Lyra SARS-CoV-2 Assay has received expanded emergency use authorization claims from the FDA to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.
Read More »BioFire Defense BioFire COVID-19 test gets EUA
March 31, 2020—BioFire Defense, a subsidiary of BioMérieux, has received emergency use authorization by the U.S. Food and Drug Administration for its BioFire COVID-19 test for use in CLIA moderate and high-complexity clinical laboratories to detect SARS-CoV-2.
Read More »Envetec 200 system for COVID-19–infected medical waste
March 31, 2020—Northwell Health, in New York, is minimizing the risk of spreading COVID-19 by adopting Technopath Clinical Diagnostics’ on-site medical waste treatment technology for COVID-19–infected medical waste.
Read More »Hardy Diagnostics releases rapid test for COVID-19
March 30, 2020—Hardy Diagnostics announced it is a U.S. supplier of the Anti-SARS-CoV-2 Rapid Test, developed by Autobio Diagnostics (Zhengzhou, China).
Read More »Biocare Medical launches seven IVD antibodies
March 27, 2020—Biocare Medical launched seven novel IVD IHC antibody markers for clinical diagnostics and research applications. This launch focuses on several immuno-oncology markers, critical in aiding early-stage cancer drug developments and patient treatment.
Read More »Roche receives FDA approval for CINtec Plus Cytology test
March 26, 2020—Roche announced FDA approval of CINtec Plus Cytology, a biomarker-based triage test for women whose primary cervical cancer screening results are positive for human papillomavirus using the Cobas 4800 HPV Test.
Read More »Diazyme COVID-19 antibody tests now available
March 25, 2020—Diazyme announced the availability of two serological tests for the novel coronavirus, the Diazyme DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA test kits. The Diazyme IgG and IgM tests are run on the fully automated Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer.
Read More »QIAstat-Dx test kit for SARS-CoV-2 available in U.S.
March 24, 2020—Qiagen has started shipping its QIAstat-Dx Respiratory SARS-CoV-2 Panel test to the United States under an FDA policy announced on March 16. Qiagen will submit this week the related emergency use authorization to the FDA.
Read More »Cepheid receives EUA for its SARS-CoV-2 test
March 23, 2020—Cepheid received emergency use authorization from the FDA for its Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2. The test is for use on the automated GeneXpert systems, with a detection time of about 45 minutes.
Read More »DiaSorin COVID-19 test gets EUA
March 20, 2020—DiaSorin Molecular announced it has received emergency use authorization from the FDA for its Simplexa COVID-19 Direct kit. The kit provides a sample-to-answer test for the detection of SARS-CoV-2 directly from nasopharyngeal swab specimens.
Read More »GenMark SARS-CoV-2 test receives EUA
March 20, 2020—The FDA has issued an emergency use authorization for GenMark Diagnostics’ ePlex SARS-CoV-2 Test. The test was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for patients suspected of COVID-19 and is for use on the company’s ePlex system, which provides results in less than two hours and can process up to 96 tests per eight-hour shift.
Read More »CDC to convene clinical lab COVID-19 response weekly calls
March 20, 2020—The Centers for Disease Control and Prevention’s Division of Laboratory Systems will convene a weekly call, beginning Monday, March 23, at 3:00 PM ET, with clinical laboratories to discuss the nation’s clinical laboratory response to COVID-19. This call will be the first of a series of weekly calls the division will host to discuss hot topics and to ...
Read More »