Globe Roche Logo

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 …

Explore

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…

Explore

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…

Explore

cobas® HIV-1 for use on the cobas® 4800 System

cobas® HIV-1 is built upon the dual-target assay design from Roche.

More

cobas® HCV for use on the cobas® 4800 System

cobas® HCV, quantitative nucleic acid test for use on the cobas® 4800 System, delivers robust, clinically relevant assay performance based on the…

More

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…

More

cobas® 4800 BRAF V600 Mutation Test

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

More

cobas® 4800 CT/NG Test

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

More

cobas® EGFR Mutation Test v2 (US-IVD)

The cobas® EGFR Mutation Test v2 (US-IVD), identifies mutations in the epidermal growth factor receptor (EGFR) gene in in tumor tissue DNA from non-small cell lung cancer (NSCLC)…

More

cobas® EGFR Mutation Test v2-RUO

The cobas® EGFR Mutation Test v2, for research use only (RUO), identifies the epidermal growth factor receptor (EGFR) gene…

More

cobas® EGFR Mutation Test v2 (CE-IVD)

The cobas® EGFR Mutation Test v2 CE-IVD, identifies the epidermal growth factor receptor (EGFR) gene in the DNA from…

More

cobas® HPV Test

The cobas® HPV Tests simultaneously detects 14 high-risk HPV types…

More

cobas® HSV 1 and 2 Test

Highly sensitive and specific test designed to reliably detect the presence of HSV-1 and HSV-2 DNA in clinical specimens.

More

cobas® KRAS Mutation Test

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

More

cobas® MRSA/SA Test

Detects Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus

More

cobas® HBV for use on the cobas® 4800 System

cobas® HBV, test for use on the cobas® 4800 System provides robust, clinically relevant assay performance with a broad…

More

New Roche HBV Test expands cobas® 4800 System menu 

Complete virology portfolio strengthens high medical value capabilities

Explore

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

System portfolio broadens to include high medical value virology assays

Explore

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

Explore

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…

Explore

Roche Receives FDA Approval for cobas® KRAS Mutation Test

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

Explore

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

Explore

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.

Explore

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.

Explore

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 …

Explore

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.

Explore

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.

Explore

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…

Explore

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…

Explore

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

Explore

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…

Explore

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…

Explore

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

Explore

Roche submits application for clearance of Chlamydia and Gonorrhoeae test

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

Explore

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

Explore

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

Explore

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

Explore

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

Explore

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

Explore