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Roche expands indication for cobas® EGFR Mutation Test v2 as a companion diagnostic with TAGRISSO®

  New indication as a companion diagnostic with AstraZeneca’s TAGRISSO® (osimertinib) in first line treatment of patients with non-small cell lung cancer (NSCLC) Results for EGFR mutations can be available in less than one day with the cobas® EGFR Mutation …

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Roche receives FDA clearance for Factor II and Factor V test on the cobas® 4800 system

Roche announced today that it has received FDA clearance for the cobas® Factor II and Factor V Test for use on the cobas® 4800 system. The test enables laboratories to simultaneously assess Factor II and Factor V gene mutations from a single patient sample, which can reduce hands-on time when testing patients for inherited thrombophilia.

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cobas® HIV-1 Test

Targets two unique regions of the HIV-1 genome on cobas® 4800/6800/8800 Systems It takes more than a single target As the challenges you face evolve, stay one step ahead with cobas® HIV-1 for use on the cobas® 4800/6800/8800 Systems, a …

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cobas® HBV Test

Confidence and precision at medically relevant decision points Delivering on clinical need requirements Hepatitis B virus (HBV) DNA detection and viral load measurement are essential for treatment decisions and patient monitoring.1 cobas® HBV for use on the cobas® 4800/6800/8800 Systems …

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cobas® HSV 1 and 2 Test

Amplify two separate regions on each of the HSV-1 and HSV-2 genomes for higher testing reliability and optimal patient treatment decisions.

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cobas® cfDNA Sample Preparation Kit

The cobas® cfDNA Sample Preparation Kit is used for manual sample preparation to isolate circulating cell-free DNA from plasma samples in combination with cobas® genomics and oncology assays, including the cobas® EGFR Mutation Test.

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Roche receives CE mark for CMV viral load testing on cobas® 4800 System

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of cobas® CMV (cytomegalovirus) for use on the automated cobas® 4800 System in countries accepting the CE mark.

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COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0: Qualitative and Quantitative

Accurately detect HCV and confidently monitor viral load results.

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cobas® CT/NG

With STI rates on the rise, cobas® CT/NG provides a solution to meet the growing demand for CT/NG Testing, delivering exceptional assay performance, providing broader information for improved patient care decisions, and enabling simplicity and flexibility to support varying throughput …

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FDA Grants Roche Label Extension for the cobas® EGFR Mutation Test v2 for use with Plasma as a Companion Diagnostic for TAGRISSO™

Roche (SIX: RO, ROG; OTCQX, RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension of the cobas® EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s …

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Roche HIV Global Access Program expands to include next-generation automated platform solutions

High throughput cobas® systems help optimize workflow for resource-limited settings Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion...

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Roche Receives FDA Approval for Use of SurePath Preservative Fluid with cobas HPV Test for Cervical Cancer Screening

Roche HPV test is first to be approved for use with the SurePath Preservative Fluid gynecologic cell collection...

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cobas®  HCV GT for use on the cobas®  4800 System

Test for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in…

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cobas® 4800 BRAF V600 Mutation Test

The cobas® 4800 BRAF V600 Mutation Test detects the BRAF V600E mutation in formalin-fixed, paraffin-embedded (FFPET)…

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cobas® 4800 CT/NG Test

A qualitative multiplex assay that simultaneously detects two CT independent DNA targets—one in the cryptic plasmid…

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cobas® HPV

Deliver 3 results in 1 test. Simultaneously detect 14 high-risk HPV types and obtain specific genotyping information for HPV 16 & 18.

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cobas® KRAS Mutation Test

Detects all of the reported mutations in KRAS codons 12, 13 and 61 to assess likelihood of patient response…

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cobas® MRSA/SA Test

Accurately identify patients suffering from C. difficile-associated disease with high assay sensitivity, rapid turnaround time and the flexibility of the cobas® 4800 System.

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New Roche HBV Test expands cobas® 4800 System menu 

Complete virology portfolio strengthens high medical value capabilities

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Roche expands cobas® 4800 System menu with HIV-1, HCV and HCV Genotyping Tests

System portfolio broadens to include high medical value virology assays

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Roche receives FDA clearance for the cobas® HSV 1 and 2 Test for the detection of herpes simplex virus

New test expands menu for sexually transmitted infections testing on the cobas® 4800 System

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Roche receives FDA clearance for the cobas® Cdiff Test to detect Clostridium difficile

New test expands menu for healthcare associated infections testing on the widely adopted cobas® 4800...

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Roche Receives FDA Approval for cobas® KRAS Mutation Test

Molecular PCR test identifies KRAS mutations to aid in determining therapy for metastatic colorectal cancer

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Roche receives FDA clearance for next generation cobas MRSA/SA Test

New test detects MRSA and SA, the leading causes of healthcare-associated infections worldwide

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FDA Approves Roche’s HPV Test for First-Line Primary Screening for Cervical Cancer

Expanded indication makes cobas® HPV Test the only test approved in U.S. that can be used instead of Pap in first-line primary screening in women 25 and older.

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Roche launches the cobas® Cdiff Test for detection of Clostridium difficile in markets accepting the CE Mark

New test expands menu for hospital-acquired infections testing on the cobas® 4800 System.

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FDA Advisory Committee Unanimously Recommends Roche’s HPV Test as Primary Screening Tool for Detection of Women at High Risk for Cervical Cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas® HPV (Human Papillomavirus) Test as a first-line …

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Roche announces launch of cobas® MRSA/SA Test in markets accepting the CE mark

New test detects methicillin-resistant Staphylococcus aureus and Staphylococcus aureus, the leading causes of healthcare acquired infections worldwide.

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Roche announces launch of the cobas® HSV 1 and 2 Test for herpes simplex virus in markets accepting the CE mark

New test expands menu for sexually transmitted infections testing on the cobas® 4800 System.

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Roche receives FDA clearance to use additional specimen types for chlamydia and gonorrhea test

Expanded application for real-time PCR-based test provides laboratories with comprehensive CT/NG test...

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Roche submits filing to FDA for cervical cancer primary screening indication for cobas® HPV Test

Approval of the expanded indication would mean the cobas® HPV Test could be used as the first-line...

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New Professional Guidelines Recognize Benefit of Genotyping HPV 16 and 18 for Cervical Cancer Prevention by Assessing Individual Patient Risk

Evidence to support DNA genotyping for HPV as a co-testing approach provided by Roche’s landmark ATHENA study

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Roche receives FDA clearance for test to screen and diagnose chlamydia and gonorrhea infection in symptomatic and asymptomatic patients

New cobas CT/NG test expands cobas 4800 system menu beyond clinically proven HPV test to further...

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Companion Diagnostic Test that Identifies Patients With Melanoma Tumor Mutation Available in Europe

cobas BRAF Mutation Test is used to identify patients with melanoma tumors that harbor a genetic...

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KRAS Diagnostic Test that assists with personalized treatment of colorectal cancer receives CE Mark

cobas KRAS Mutation Test identifies colorectal cancer patients not likely to respond to anti-EGFR antibody therapies

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Roche submits application for clearance of Chlamydia and Gonorrhoeae test

Test detects and expands menu on the recently approved cobas 4800 instrument

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Roche obtains license for EGFR lung cancer assays and will develop Tarceva companion diagnostic test

Molecular assay aims to enhance personalized treatment with Tarceva by detecting EGFR activating mutations

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Roche and German Cancer Research Center (DKFZ) Enter Research Agreement to Predict Cervical Cancer

Collaboration is based on recent DKFZ discovery suggesting cervical cancer risk may be more precisely determined

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Roche obtains co-exclusive license to develop PCR assays detecting mutations in the PI3K oncogene

Roche obtains co-exclusive license to develop PCR assays detecting mutations in the PI3K oncogene

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A New Study Shows that Testing for HPV Genotypes 16 and 18 Detects Cervical Pre-Cancer Missed by Pap Test

1 in 10 women in the ATHENA trial, age 30-years and older, who tested positive for HPV genotypes 16 and/or 18 by the cobas® 4800 HPV Test had cervical pre-cancer, although their Pap test was normal Involving more than 47,000 women, the ATHENA trial is the largest registration study ever conducted for cervical cancer screening

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Roche introduces new automated clinical laboratory system for CE-Marked testing of human papillomavirus, Chlamydia and N. gonorrhoeae

New cobas 4800 System designed to increase laboratory efficiency and medical value

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