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 »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 »Roche launches Elecsys HBeAg quant in CE markets
January 2024—Roche launched the Elecsys HBeAg quant, an immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen in human serum and plasma. In conjunction with other laboratory results and clinical information, HBeAg quantification may be used as an aid in the diagnosis and monitoring of patients with hepatitis B viral infection. It is for use on Cobas e analyzers in countries that accept the CE mark.
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 »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 »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 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 »FDA expands approval for Ventana PD-L1 assay
May 2023—Roche announced FDA approval of the Ventana PD-L1 (SP263) assay as a companion diagnostic to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for treatment with Libtayo (cemiplimab-rwlc), a PD-1 inhibitor therapy developed by Regeneron. Libtayo’s approval is based on results of the phase three EMPOWER-Lung 1 study. The OptiView DAB IHC detection kit is used for staining on a BenchMark Ultra instrument.
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 »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 »Roche launches antibody to identify PRAME protein expression
January 2023—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. Studies suggest that the detection of PRAME expression by immunohistochemistry complements findings from routinely used tests and enables more informed clinical decisions and improved patient outcomes, according to a company press release.
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 »Roche gets EUA for high-throughput monkeypox test
December 2022—Roche announced that the FDA has granted emergency use authorization for the Cobas MPXV for use on Cobas 6800/8800 systems. The real-time PCR test is for the qualitative detection of DNA from monkeypox virus in lesion swabs collected from individuals suspected of having monkeypox infection by their health care provider. The assay uses β-globin as an endogenous control to assess specimen adequacy. It detects monkeypox nucleic acids and the endogenous control in the same well.
Read More »Roche introduces Cobas 5800 to expand access to PCR testing in the U.S.
December 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 »FDA clears COVID-19 PCR test on Cobas 6800/8800 systems
November 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. It is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal swab specimens collected from symptomatic patients who are suspected of having COVID-19 by their health care provider. The single-well, dual-target assay includes specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus that includes SARS-CoV-2.
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 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 »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 »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 »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 »Roche launches digital PCR system
October 2022—Roche launched its Digital LightCycler system, the company’s first digital polymerase chain reaction system, for precise DNA and RNA analysis in areas such as oncology and infectious diseases. The instrument features three unique reaction plates, six channel multiplexing capabilities, and a 5× concentrated master mix reagent. Run time is two to four hours with up to 96 samples per run.
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 »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 »Roche receives EUA for Cobas SARS-CoV-2 Duo
September 2022—Roche announced that the FDA issued emergency use authorization for the Cobas SARS-CoV-2 Duo for use on the fully automated Cobas 6800/8800 systems. The real-time RT-PCR assay is for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. The assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of the assay is intended for use as an aid in diagnosing SARS-CoV-2 infection in patients suspected of COVID-19 by their health care provider.
Read More »Roche COVID-19 test detects, differentiates BA.2.75
September 2022—Roche and its subsidiary TIB Molbiol have developed a COVID-19 test that detects and differentiates the BA.2.75 subvariant. The VirSNiP SARS-CoV-2 Spike 147E 152R test, for research use only, targets two of the known unique mutations, K147E and W152R, in BA.2.75, which allows clear differentiation against other notable subvariants. The test is for use on the Lightcycler and Cobas z480 instruments and is available worldwide.
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 »Roche launches BenchMark Ultra Plus, Ventana DP 600
August 2022—Roche has launched its BenchMark Ultra Plus tissue staining platform. The system was built on the technology of the BenchMark Ultra and uses improved Ventana system software, which aims to enhance quality control and inventory management.
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 »Roche launches Cobas Pulse system
April 2022—Roche announced the launch of the Cobas Pulse system, the company’s newest generation of connected POC solutions for professional blood glucose management, in select countries accepting the CE mark.
Read More »Roche COVID-19 at-home test granted EUA
February 2022—Roche announced that the FDA has granted emergency use authorization for its COVID-19 At-Home Test. The test uses an anterior nasal swab sample that can be self-collected and self-tested by people ages 14 years and older and by an adult for children ages two to 13 years old. Results are available in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including omicron.
Read More »Roche launches Cobas 5800 molecular Dx system in CE markets
January 2022—Roche launched its Cobas 5800 system in countries accepting the CE mark. The real-time PCR molecular testing solution is built to offer a fully automated workflow that encompasses sample supply, transfer and preparation, amplification and detection, result calculation, and delivery to the laboratory information system. The single module enables a walkaway time of up to eight hours.
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 »Roche launches three respiratory panels in CE markets
November 2021—Roche launched in the CE market three molecular PCR diagnostic test panels to simultaneously detect and differentiate flu A, flu B, and respiratory syncytial virus; adenovirus, human metapneumovirus, and enterovirus/rhinovirus; and parainfluenza 1, 2, 3, and 4. The tests can be run together or individually from a single nasopharyngeal swab specimen and run on the Cobas Omni Utility Channel for use with the Cobas 6800/8800 systems.
Read More »Roche POC SARS-CoV-2 test gets EUA
September 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. The singleplex, RT-PCR test screens within 20 minutes both asymptomatic and symptomatic persons. The test, for point-of-care use, offers broad strain coverage of SARS-CoV-2 variants.
Read More »Cobas SARS-CoV-2 Test authorized for asymptomatic people
August 2021—Roche’s Cobas SARS-CoV-2 has received FDA emergency use authorization for testing individuals without symptoms or reasons to suspect COVID-19. This authorization supports the guidance update from the CDC to expand SARS-CoV-2 testing to include people without symptoms and applies to pooled samples containing up to and including six individual samples. Asymptomatic testing with the Cobas SARS-CoV-2 test is also available in countries accepting the CE mark.
Read More »Roche launches Elecsys Epstein-Barr virus immunoassay panel
July 2021—Roche’s Elecsys EBV panel has launched in countries accepting the CE mark. The panel consists of the Elecsys EBV IgM, EBV VCA IgG, and EBV EBNA IgG immunoassays and detects antibodies specific to the Epstein-Barr virus at different stages of infection.
Read More »Roche adds high-throughput configurations to Cobas Pro
July 2021—Roche launched eight configurations for its Cobas Pro integrated solutions, in countries accepting the CE mark. As a result, the analyzer can deliver up to 4,400 tests per hour, doubling its previous testing capacity. It is now possible to add two analytical units of Cobas c 503 and/or Cobas e 801, consolidating up to four analytical units on one platform.
Read More »Roche to acquire GenMark Diagnostics
June 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. GenMark’s syndromic panel testing portfolio will complement Roche’s molecular diagnostics portfolio, and Roche’s global network will enable expanded reach for GenMark’s products.
Read More »Roche launches Discovery Green HRP kit
June 2021—Roche launched its Discovery Green horseradish peroxidase (HRP) kit, to identify and profile biomarkers and cell populations in tissue-based research.
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 »Roche launches SARS-CoV-2 variant test
May 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). This research use only laboratory test can be used to help scientists track mutation prevalence and to assess potential impact on diagnostics, vaccines, and therapeutics.
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 »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 »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 »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 »Roche CE-marked Cobas PIK3CA Mutation Test
January 2021—Roche launched the Cobas PIK3CA Mutation Test CE-IVD for patients with advanced or metastatic breast cancer in countries accepting the CE mark. The test was previously available for research use only.
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 »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 »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 »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 »Newsbytes
August 2020—At Sonora Quest Laboratories, working backward has been a key strategy for leaping forward. Little by little, the Arizona-based integrated laboratory system has been retracing paper trails and assessing established processes as part of an ambitious plan to eliminate paper use across its seven commercial laboratories, 28 hospital labs, and more than 75 patient service centers.
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 »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 »Roche’s Elecsys IL-6 test receives FDA EUA
July 2020—Roche announced that the FDA has issued an emergency use authorization for the Elecsys IL-6 test, which measures levels of the biomarker interleukin 6 in human serum or plasma. The assay can be used to assist in identifying severe inflammatory response in patients with confirmed COVID‑19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.
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 »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 »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 »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 »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 »EC approves venetoclax + obinutuzumab for CLL
April 2020—Roche announced that the European Commission has approved Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia.
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 »Roche expands portfolio with adenovirus test
March 2020—Roche announced the commercial availability of a quantitative Adenovirus Test for use with the Cobas Omni utility channel on the Cobas 6800/8800 systems in countries accepting the CE mark. The test aims to help health care professionals better monitor and manage severely immunocompromised transplant patients at risk of infections.
Read More »Roche, Sarepta enter licensing agreement
February 2020—Roche and Sarepta Therapeutics signed a licensing agreement providing Roche exclusive commercial rights, outside the United States, to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sarepta’s investigational gene therapy for Duchenne muscular dystrophy. Under the terms of the agreement, Sarepta will receive an upfront payment of $750 million in cash and $400 million in equity. In addition, Sarepta is eligible to receive regulatory and sales milestones, and royalties on net sales. Roche and Sarepta will equally share global development expenses. As part of the agreement, Roche also obtains an option to acquire ex-U.S. rights to certain future DMD-specific programs from Sarepta, in exchange for separate milestone and royalty considerations, and cost sharing.
Read More »FDA approves Tecentriq combo for NSCLC
February 2020—Roche announced FDA approval of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. The European Commission approved the combination therapy in September.
Read More »Roche launches Zika test to markets accepting the CE mark
Dec. 23, 2019—Roche announced the CE-IVD launch of the Cobas Zika test for use on the Cobas 6800/8800 systems. The test detects Zika virus RNA in samples of human plasma and is intended for use in screening blood donations.
Read More »Roche launches Cobas EBV, BKV tests
December 2019—Roche announced the commercial availability of the Cobas EBV (Epstein-Barr virus) and Cobas BKV (BK virus) tests for use on the Cobas 6800/8800 systems in countries accepting the CE mark. The tests are used to assess if transplant patients are at risk of developing disease by these pathogens, which can contribute to organ rejection.
Read More »EC approves Tecentriq-based combo therapy for NSCLC
December 2019—Roche announced that the European Commission has approved and granted marketing authorization for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel]) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer who do not have EGFR mutant or ALK-positive NSCLC.
Read More »Newsbytes
Francisco Partners to acquire Orchard Software
November 2019—Francisco Partners, a technology-focused private equity firm, announced Sept. 30 its intent to acquire Orchard Software. CAP TODAY publisher Bob McGonnagle, on Oct. 2, spoke with Orchard founder and CEO Rob Bush and with Billie Whitehurst, who will succeed Bush as CEO. Whitehurst most recently was senior vice president at Netsmart. Here is what they, and Curt Johnson and Kerry Foster, of Orchard, had to say about the acquisition.
Roche launches Navify cancer guidelines app
Oct. 24, 2019—Roche has released the Navify Guidelines app as part of its Navify Decision Support portfolio.
Read More »Roche launches Cobas EBV, BKV tests on 6800/8800 systems
Sept. 30, 2019—Roche announced the commercial availability of the Cobas EBV (Epstein-Barr virus) and Cobas BKV (BK virus) tests for use on the Cobas 6800/8800 systems in countries accepting the CE mark. The tests are used to assess transplant patients' risk of developing disease by these pathogens, which can contribute to organ rejection.
Read More »FDA approves Cobas Babesia
Sept. 20, 2019–Roche received FDA approval for the Cobas Babesia test for use on the Cobas 6800 and Cobas 8800 systems. It is a qualitative in vitro nucleic acid screening test for the direct detection of babesia (B. microti, B. duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors.
Read More »Roche launches PD-L1 assay in CE markets as CDx for TNBC
Aug. 30, 2019—Roche announced the expanded use of its Ventana PD-L1 (SP142) Assay in triple-negative breast cancer for patients living in CE markets where Tecentriq is approved. It is the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab) plus chemotherapy (nab-paclitaxel). The announcement follows the FDA approval of the assay in March as the first companion diagnostic to identify triple-negative breast cancer patients eligible for the Tecentriq combination.
Read More »Roche, Bio-Techne expand partnership
July 2019—Roche is expanding its partnership with Bio-Techne by offering chromogenic detection kits for automated in situ hybridization tissue analysis.
Read More »Roche launches IVD IHC test to detect ROS1 protein in cancer
June 10, 2019—Roche launched its Ventana ROS1 (SP384) Rabbit Monoclonal Primary Antibody, an in vitro diagnostic ROS1 immunohistochemistry assay that detects the presence of ROS1 protein in tissue and may be useful in identifying ROS1-positive cancer cases.
Read More »TV/MG test added to Cobas 6800/8800 menu
May 31, 2019—The Food and Drug Administration cleared the Cobas TV/MG test for use on the Cobas 6800/8800 systems for the detection of Trichomonas vaginalis and/or Mycoplasma genitalium DNA in symptomatic and asymptomatic patients. Laboratories can now simultaneously process from a single sample a combination of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.
Read More »Ipatasertib combo shows promising anti-tumor activity
May 2019—Roche presented at the American Association for Cancer Research annual meeting the initial results from a phase one-b study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq (atezolizumab) and chemotherapy (paclitaxel or nab-paclitaxel (Abraxane [paclitaxel albumin-bound particles for injectable suspension]) as a first-line treatment option for people with advanced triple-negative breast cancer.
Read More »Roche to acquire Spark Therapeutics
May 2019—Roche and Spark Therapeutics entered into a definitive merger agreement for Roche to fully acquire Spark Therapeutics for about $4.3 billion.
Read More »Roche launches Ventana HER2 Dual ISH DNA probe assay
April 25, 2019—Roche announced the launch of the Ventana HER2 Dual ISH DNA Probe Cocktail assay to detect the HER2 biomarker in breast and gastric cancer patients to aid in determining who might be eligible for the targeted drug trastuzumab (Herceptin, Roche).
Read More »Roche launches Navify Mutation Profiler, Therapy Matcher
March 27, 2019—Roche announced the CE-IVD mark and launch of its Navify Mutation Profiler, clinical software that provides annotation, interpretation, and clinical reporting
Read More »Ventana PD-L1 (SP142) assay approved as CDx for TNBC
March 22, 2018—Roche announced FDA approval of the Ventana PD-L1 (SP142) Assay as the first companion diagnostic
Read More »FDA approvals for Roche oncology drugs
March 2019—Roche announced FDA approval of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and paclitaxel and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
Read More »Roche’s Xofluza approved for influenza treatment
February 2019—Roche announced that the FDA has approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. Xofluza is a single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease.
Read More »Tecentriq combo for TNBC prolongs PFS
January 2019—The FDA has accepted Roche’s supplemental biologics license application and granted priority review to the company’s Tecentriq in combination with Abraxane (nab-paclitaxel, Celgene) for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer.
Read More »Roche launches IVD pan-TRK IHC assay
Nov. 29, 2018—Roche announced the worldwide launch of the Ventana pan-TRK (EPR17341) Assay, an automated in vitro diagnostic immunohistochemistry assay to detect tropomyosin receptor kinase proteins in cancer. The CE IVD/U.S. class I assay is designed to detect C-terminal protein expression, which allows for the detection of TRK-fusion as well as wild-type protein expression. “As the first test of its kind, ...
Read More »Study: Kadcyla improved invasive disease-free survival
November 2018—Roche announced the phase three KATHERINE study met its primary endpoint, showing Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival) compared with trastuzumab as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment.
Read More »Hemlibra for hemophilia A without FVIII inhibitors approved
Oct. 5, 2018—Roche announced the FDA’s approval of Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors.
Read More »Roche announces availability of FoundationOne Liquid
Sept. 27, 2018—Roche announced that its FoundationOne Liquid, a blood-based genomic profiling test, is available worldwide. FoundationOne Liquid can identify circulating tumor DNA in the blood of people with cancer and can identify 70 of the most commonly mutated genes in solid tumors, including microsatellite instability.
Read More »MU School of Medicine, Roche team up
September 2018—Roche announced the result of a collaboration with the University of Missouri School of Medicine to implement the company’s Navify tumor board solution, cloud-based clinical workflow and decision-support software to assist with cancer patient case reviews in tumor board and multidisciplinary team meetings.
Read More »FDA approves Cobas HPV Test with SurePath
Aug. 3, 2018—Roche has received FDA approval for the Cobas HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using specimens collected in SurePath preservative fluid. The Roche test is now the only HPV test approved for use as a primary screening test with both SurePath and ThinPrep PreservCyt Solution. It ...
Read More »Roche showcases new test options at ASM Microbe
June 8, 2018—Roche will feature at ASM Microbe 2018, in Atlanta, new test options that aim to expand the opportunities for laboratories to automate molecular testing. The company is introducing its CT/NG test for its Cobas 6800 and 8800 systems. The test, which was cleared by the FDA in April, allows laboratories to consolidate STI testing with Roche’s viral load ...
Read More »Roche to acquire Ignyta, 4/18
April 2018—Roche will acquire San Diego–based Ignyta for $27.00 per share in cash, or $1.7 billion. Ignyta, which will continue its operations in San Diego, focuses on precision medicine in oncology aiming to test, identify, and treat patients with cancers harboring specific rare mutations.
Read More »CE-marked Cobas Plasma Separation Card, 4/18
April 2018—Roche launched the Cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. By requiring only a small amount of a patient’s blood from a fingertip, this card simplifies blood collection and sample transportation, as compared with traditional plasma-based testing.
Read More »Roche, GE to develop digital diagnostics platform, 4/18
April 2018—Roche and GE Healthcare will partner to develop and co-market digital clinical decision support solutions. The companies aim to develop a digital platform using analytics to provide workflow solutions and apps that support clinical decisions. This will allow the integration and analysis of in vivo and in vitro data, patient records, medical best practices, real-time monitoring, and the latest research outcomes.
Read More »Discovery Teal HRP chromogen detection kit, 3/18
March 2018—Roche launched the Discovery Teal HRP kit, a modular-based detection kit to identify and profile biomarkers and cell populations in tissue-based research.
Read More »Roche gains CE mark for expanded use of PD-L1 assay,11/17
November 2017—Roche announced the expanded use of the Ventana PD-L1 (SP142) Assay in non-small cell lung cancer and metastatic urothelial carcinoma in CE markets in which the Roche cancer immunotherapy medicine Tecentriq is approved.
Read More »FDA-approved tests for Roche instruments, 9/17
September 2017—Roche received FDA approval for the Cobas CMV test for use on its Cobas 6800 and Cobas 8800 Systems. The test is standardized to the 1st WHO International Standard for improving harmonization in cytomegalovirus testing results across hospital institutions.
Read More »Cobas Liat PCR system with four assays, 7/17
July 2017—Roche announced the CE-IVD launch of the Cobas Liat PCR System with four assays, including a 20-minute real-time PCR nucleic acid test to detect Clostridium difficile.
Read More »FDA-cleared next-gen troponin T test, 6/17
June 2017—Roche received 510(k) clearance for its Elecsys Troponin T Gen 5 STAT blood test for patients with a suspected heart attack. With this clearance, according to a company statement, Roche is the first IVD company in the U.S. to provide next-generation troponin testing for patients as an aid in the diagnosis of myocardial infarction, enabling clinicians to more accurately identify patients experiencing a heart attack.
Read More »FDA clearance for Roche analyzer, assay, 3/17
March 2017—Roche announced that its dedicated, high-throughput HbA1c testing solution, the Cobas c 513 analyzer, and HbA1c Gen. 3 assay have received 510(k) clearance from the Food and Drug Administration.
Read More »Fully automated fluorescent multiplex procedure, 2/17
February 2017—Roche launched its Discovery 5-Plex procedure and reagents for immunohistochemistry research applications. This is the first pre-optimized, fully automated multiplex procedure available on the Ventana Discovery Ultra instrument.
Read More »High-volume platforms, inventory solutions, 10/16
October 2016—Roche launched its presence by featuring several next-generation diagnostic testing platforms and a virtual reality experience that was designed to give attendees an “under the hood” look at a lab of the future and a concept Roche calls the “Roche connected lab.”
Read More »Target enrichment systems, 9/16
September 2016—Roche announced the worldwide launch of the Heat-Seq Target Enrichment Systems, which provide rapid and accurate enrichment methods designed to improve the detection of variants in human genetics and cancer research.
Read More »Chromogen for cancer research, 5/16
May 2016—Roche announced the launch of the Discovery Yellow Kit, an alkaline phosphatase-based detection chemistry for tissue diagnostics that produces a unique, transparent yellow signal that is not washed away during alcohol dehydration.
Read More »H&E tissue staining solution, 2/16
February 2016—Roche launched the Ventana HE 600 system, its latest fully automated hematoxylin and eosin tissue staining system designed to enhance patient and technician safety and produce exceptional staining quality.
Read More »FDA-approved viral load tests, 12/15
December 2015—Roche received FDA approval for the Cobas HBV and Cobas HCV viral load tests for use on the Cobas 6800 and Cobas 8800 systems. Cobas HBV is a real-time PCR test designed to offer an expanded linear range coupled with broad coverage of all known HBV genotypes (A–H), including pre-core mutations with improved sensitivity.
Read More »Whole exome sequencing solution, 11/15
November 2015—Roche has launched the SeqCap EZ Med-Exome Target Enrichment Kit, a comprehensive whole exome sequencing solution designed to increase the discovery and detection of human genetic variants associated with disease while reducing sequencing costs. For research use only; not for use in diagnostic procedures.
Read More »Roche to acquire Kapa Biosystems, 10/15
Roche has signed a definitive agreement to acquire Kapa Biosystems, a privately held company that employs proprietary technologies to optimize enzymes for next-generation sequencing as well as polymerase chain reaction and real-time PCR applications.
Read More »Educational initiative, new platforms, 9/15
Roche introduced next-generation diagnostic testing platforms and an educational initiative that demonstrates how it’s partnering with customers to redefine the value of the laboratory.
Read More »Roche purchases tissue dissection technology, 2/15
February—Roche Diagnostics has signed a definitive purchase agreement with AvanSci Bio for all products associated with the high-performance microdissection of slide-mounted tissue sections. The system consists of instrumentation, software, and consumables used by researchers and clinicians to extract specific areas of tissue with high precision and purity for subsequent molecular analysis including real-time PCR, microarrays, and sequencing.
Read More »Roche, ARK distribution agreement, 12/14
December 2014—Roche and ARK Diagnostics announced a distribution agreement that will enable laboratories to integrate ARK’s Methotrexate test into the Roche therapeutic drug monitoring menu for its Cobas c 501 and Cobas c 502 clinical chemistry analyzers.
Read More »Roche products and acquisitions, 9/14
September 2014—New products featured by Roche this year include analyzers, an automated workflow series, and assays. The Cobas u 601 urine analyzer is a fully automated solution for urine strip testing in mid- to high-volume labs that delivers high-quality results through reagent test strips. This analyzer is not available for sale in the U.S.; a 510(k) submission is pending.
Read More »Health Canada approves Roche’s HPV test, 7/14
July 2014—Health Canada approved Roche’s Cobas 4800 HPV Test for use as a first-line primary screening test for cervical cancer in women 25 and older. Roche also launched the fully automated CINtec Plus test to improve the detection and early intervention of precancerous cervical disease. The Health Canada–approved CINtec Plus cytology test helps identify women with high-grade precancerous cervical lesions who need immediate colposcopy.
Read More »Streamlined workflow for HPV test, 9/13
The FDA in June approved a workflow process for Roche Diagnostics’ Cobas HPV test that allows sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. The approval allows labs to load the same vial used for a ThinPrep Pap test directly onto Roche’s Cobas 4800 system for high-risk HPV and individual HPV ...
Read More »Intelligent lab automation solution, 9/13
Roche’s Cobas 8100 automated workflow series is an advanced system designed to automate many routine tasks to help diagnostic laboratories increase efficiency, reduce expenses, and maximize patient safety. Through intelligent robotics, the Cobas 8100 series automatically prepares blood samples for immediate testing and post-analytical processing, providing high-speed processing of up to 1,100 samples per hour. The system offers dynamic and ...
Read More »Streamlined workflow for Roche HPV test, 8/13:86
The FDA has approved a workflow process for Roche Diagnostics’ Cobas HPV test that allows sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. Labs can load the same vial used for a ThinPrep Pap test directly onto the Cobas 4800 system for high-risk HPV and individual HPV 16 and 18 genotype ...
Read More »Erlotinib tablets and EGFR mutation test, 7/13:104
The FDA has approved Roche Diagnostics’ Tarceva (erlotinib) tablets for the initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR)-activating mutations as detected by an FDA-approved test. The FDA also approved Roche’s Cobas EGFR mutation test. In the United States, Tarceva is already approved, irrespective of histology or biomarker ...
Read More »Roche, Hamilton introduce automated platform for DNA sample enrichment, 4/13:84
Roche and Hamilton Robotics have introduced an integrated platform that enables automated DNA sample enrichment for Roche’s 454 GS Junior sequencer. The platform builds on the integration of Roche’s REM e system with Hamilton’s Microlab Nimbus NGS workstation, resulting in reduced hands-on time, minimized operational variability, and more consistent results.
Read More »Next-gen HCV test, 4/13:86
Roche has received FDA approval for its Cobas AmpliPrep/Cobas TaqMan HCV test, v2.0. The next-generation viral load test is for use in the management of patients with chronic hepatitis C virus infection. The test provides a novel dual-probe approach, for an extra layer of protection in detecting and quantifying the virus and is designed to accurately determine the amount of HCV RNA to assess a patient’s response to antiviral therapy.
Read More »