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Tag Archives: Roche

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.

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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.

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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.  

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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.

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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.

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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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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.

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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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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 trachomatisNeisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.

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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.

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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.

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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.

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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, ...

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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.

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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.

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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.

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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 ...

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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 ...

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 ...

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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 ...

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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 ...

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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 ...

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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.

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