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Keep up-to-date with the latest trends in management and clinical operation, regulatory changes, and finance.

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.

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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.

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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.

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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 ...

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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.

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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.

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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 ...

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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 ...

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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 ...

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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.

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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 ...

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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)

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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.

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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

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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).

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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.

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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.

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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.

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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).

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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

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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).

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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).

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Enhertu approved for patients with HER2-low metastatic breast cancer

August 8, 2022—AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

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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 ...

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 ...

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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 ...

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 ...

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Abbott launches novel coronavirus test

March 19, 2020—Abbott has received emergency use authorization from the FDA for its molecular test for the identification of SARS-CoV-2. The Abbott RealTime SARS-CoV-2 EUA test can be used on Abbott’s m2000 RealTime system by authorized laboratories in the U.S.

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FDA expands policy on COVID-19 testing

March 19, 2020—The FDA updated on March 16 a policy originally issued on Feb. 29 on diagnostic testing for COVID-19 in order to achieve more rapid testing capacity in the U.S. The updated guidance, which addresses laboratories and commercial manufacturers, will help to expand the number and variety of diagnostic tests, as well as available testing capabilities, in health care settings and reference and commercial laboratories.

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BD, BioGX announce EUA submissions for COVID-19 dx

March 18, 2020—BD and BioGX have submitted emergency use authorization requests to the FDA for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 by thousands of tests per day. The tests will be run on the BD Max molecular diagnostic platform, which can process 24 samples simultaneously.

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QIAstat-Dx panel for SARS-CoV-2 launches in Europe

March 18, 2020—Qiagen has obtained the CE mark for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic for the detection of SARS-CoV-2. The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour.

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Quidel receives EUA for molecular COVID-19 assay

March 18, 2020—Quidel has received emergency use authorization from the FDA to market its Lyra SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19.

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Hologic’s test for SARS-CoV-2 receives EUA

March 17, 2020—Hologic announced on March 16 that the FDA has granted emergency use authorization for its Panther Fusion SARS-CoV-2 assay. The real-time RT-PCR in vitro diagnostic test is intended for the qualitative detection of RNA from the SARS-CoV-2 isolated and purified from nasopharyngeal and oropharyngeal swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria.

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Qiagen ships QIAstat-Dx test kits for SARS-CoV-2

Feb. 27, 2020—Qiagen announced it has shipped its newly developed QIAstat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China for evaluation and is in the process of shipping QIAstat-Dx testing kits to public health institutions in other regions, including Europe, Southeast Asia, and the Middle East.

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