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Roche launches cobas® CT/NG on the cobas® 6800/8800 Systems in markets accepting the CE mark

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE-IVD launch of cobas® CT/NG, for use on the cobas® 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals. …

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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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Roche receives FDA approval for fully automated blood screening assay on the cobas® 6800/8800 Systems

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas® MPX test for use on the cobas® 6800 and 8800 Systems. The cobas® MPX test enables …

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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 receives CLIA waiver for cobas® Influenza A/B & RSV test for the cobas® Liat®

The first CLIA-waived, real-time PCR test that differentiates flu and RSV in 20 minutes is available now for use in physician offices and urgent care settings.

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

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

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FDA Grants First Liquid Biopsy Approval to the Roche cobas® EGFR Mutation Test v2

Test can be used with either plasma or tumor tissue, as a companion diagnostic for non-small cell lung cancer therapy.

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Roche announces the first FDA-approved CMV test for use in hematopoietic stem cell transplant recipients

New test standardizes CMV testing for both solid organ and hematopoietic stem cell transplant recipients.

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Roche receives approval in Japan for the cobas® EGFR Mutation Test v2 

New test includes expanded mutation coverage to detect EGFR mutations in non-small cell lung cancer patients.

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cobas® Influenza A/B and RSV Assay

The cobas® Influenza A/B and RSV nucleic acid test for use on the cobas® Liat® System is an automated multiplex real-time RT-PCR assay for…

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cobas® Influenza A/B Assay

The cobas® Influenza A/B nucleic acid test, for use on the…

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cobas® Strep A Assay 

The cobas® Strep A nucleic acid test, for use on the cobas® Liat® System, is a qualitative in vitro diagnostic test for the detection of…

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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…

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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® AmpliPrep/COBAS® TaqMan® CMV Test

Real-time, fully automated nucleic acid amplification test to reliably monitor cytomegalovirus (CMV) infection in patients…

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COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0

Fully automated viral load quantitative hepatitis B test used in the management of patients with chronic hepatitis B infection undergoing antiviral therapy.

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

Detection of HCV RNA using a qualitative test confirms HCV antibody-positive specimens and provides evidence of an active infection.

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

Confidently monitor treatment response to HCV therapies with a highly sensitive limit of quantitation.

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COBAS® AmpliPrep/COBAS® TaqMan® HCV Test

An in vitro nucleic acid amplification test for the quantitation of HCV RNA in human plasma or serum.

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COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test

A qualitative nucleic acid amplification test* for the detection of HIV-1 RNA and proviral DNA in plasma, anticoagulated fresh whole blood and dried blood spots.

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COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0

An in vitro nucleic acid amplification test for the quantitation of HIV-1 RNA in human plasma that targets two regions of the HIV-1 genome.

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COBAS® AmpliPrep/COBAS® TaqMan® HLA-B*5701 Screening Test

Use PCR technology to facilitate HLA-B*5701 screening and better manage HIV patients who could potentially have hypersensitivity reactions to abacavir.

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COBAS® AmpliScreen HBV Test

A PCR test that detects the presence of HBV DNA in plasma or blood, organ and tissue donors.

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COBAS® AmpliScreen HCV Test, v2.0

A PCR test that detects the presence of HCV RNA in plasma of blood, organ and tissue donors.

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COBAS® AmpliScreen HIV-1 Test, v1.5

A polymerase chain reaction (PCR) test for the detection of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma.

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cobas® DNA Sample Preparation Kit

The cobas® DNA Sample Preparation Kit is used for manual sample preparation to process FFPET specimens and isolate…

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cobas® DPX

The cobas® DPX test, for use on the cobas® 6800 and 8800 Systems, is a multi-dye, duplex…

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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)…

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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…

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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…

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cobas® HBV for use on the cobas® 6800/8800 System

cobas® HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma or serum of HBV-infected individuals.

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cobas® HCV for use on the cobas® 6800/8800 Systems

Quantitative nucleic acid test designed to deliver high sensitivity to meet the requirements of current…

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cobas® HEV

Qualitative, real-time PCR test for the direct detection of hepatitis E virus (HEV) in human plasma.

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cobas® HIV-1 for use on the cobas® 6800/8800 System

Nucleic acid amplification test for the quantitation of HIV-1 in EDTA plasma that targets two unique regions…

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cobas® HPV Test

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

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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.

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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® MPX

Detects and discriminates the most critical viral targets in one easy-to-use assay.

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cobas® MRSA/SA Test

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

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cobas® PIK3CA Mutation Test

The cobas® PIK3CA Mutation Test is a real-time PCR test for the…

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COBAS® TaqMan® CT Test, v2.0

CT assay simultaneously detects two Chlamydia trachomatis (CT) independent DNA targets.

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COBAS® TaqMan® HBV Test For Use With The High Pure System 

Hepatitis B virus (HBV) viral load quantification test used in the management of patients with chronic HBV…

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COBAS® TaqMan® HCV Test v2.0 For Use With The High Pure System

Utilizes real-time PCR technology for the detection and quantitation of HCV RNA genotypes 1-6 as an aid…

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COBAS® TaqMan® HIV-1 Test, v2.0 For Use With The High Pure System

An advanced and reliable HIV-1 viral load detection with a dual-target approach

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COBAS® TaqMan® MTB Test

Real-time PCR test for qualitative detection of Mycobacterium tuberculosis (MTB) complex DNA

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cobas® TaqScreen DPX Test

A real-time polymerase chain reaction (PCR) assay that detects parvovirus B19 (B19V) and hepatitis A virus (HAV) in human plasma

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cobas® TaqScreen MPX Test

A multiplex, real-time PCR test that detects the presence of human immunodeficiency virus type 1 (HIV-1, groups M and O), human immunodeficiency virus type 2 (HIV-2), hepatitis C virus (HCV) and hepatitis B virus…

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cobas® TaqScreen MPX Test, v2.0

A multiplex, real-time PCR test that offers immediate virus discrimination of HIV, HCV and HBV in donations of human whole blood and blood components including source plasma.

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cobas® TaqScreen West Nile Virus Test

A real-time PA real-time polymerase chain reaction (PCR) donor screening test to detect West Nile virus (WNV) RNA in plasma from blood, organ and tissue donors.CR test to detect West Nile virus (WNV) RNA in plasma from blood, organ and tissue donors with broad cross reactivity to other flavivirus.

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cobas® WNV

Detects mosquito borne TTID to provide extra level of safety

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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…

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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 receives FDA approval for HIV-1 viral load test on the cobas® 6800/8800 Systems

HIV-1 test expands menu for highly automated molecular platforms that offer fastest time to results.

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Roche receives FDA approval for cobas® EGFR Mutation Test v2 as a companion diagnostic for non-small cell lung cancer therapies

Next-generation test using tissue samples is approved for use as a companion diagnostic with AstraZeneca’s new therapy, TAGRISSO™

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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 approval for viral load tests and cobas® 6800/8800 Systems

Roche receives FDA approval for viral load tests and cobas® 6800/8800 Systems. cobas®6800/8800 Systems offer fastest time to results and highest throughput of any molecular platform, helping to improve disease management and patient care.

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Roche launches the cobas® EGFR Mutation Test v2 for use with either plasma or tumour tissue samples

New test is the first to be validated for use of either sample type in a single test.

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Roche receives FDA CLIA waiver for Influenza A/B test for use on its cobas® Liat® PCR System

Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System

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Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy

The cobas® EGFR Mutation Test v2 is designed for expanded EGFR mutation detection in non-small cell…

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Roche expands HIV Global Access Program to include infants in resource limited settings

Program adds early infant testing to further support the  90:90:90 UNAIDS goal

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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 CLIA Waiver for the cobas Liat PCR System and Strep A assay

cobas Strep A, the first molecular PCR test to deliver laboratory quality results in ~15 minutes, now…

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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 launches next-generation duplex test for parvovirus B19 and hepatitis A in markets accepting the CE mark

Cobas® DPX assay increases safety of human plasma and plasma products

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Roche launches next-generation viral load assay for HBV in markets accepting the CE mark

Cobas HBV assay offers unparalleled performance on the cobas 6800/8800 Systems

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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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Roche launches next-generation viral load assay for CMV in markets accepting the CE mark

cobas® CMV assay offers unparalleled performance on the cobas® 6800/8800 Systems.

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Roche launches next-generation viral load testing assays for new molecular diagnostic platforms in markets accepting the CE mark

cobas HIV-1 and HCV assays offer unparalleled performance on cobas 6800/8800 Systems.

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Roche Receives FDA Clearance for Strep A Test on cobas® Liat® System

The cobas Strep A test is the first molecular point of care test to provide a result in 15 minutes for this…

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Roche launches new fully automated molecular diagnostic systems offering the fastest time to results with the highest testing capacity

The cobas 6800/8800 Systems offer advanced performance with next generation donor screening assays.

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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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Roche receives FDA approval for cobas p 630 pre-analytical solution for automated molecular testing platform

New instrument, software integrate automated primary tube handling with fully automated platform for sample preparation, amplification and detection

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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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New Roche screening test for abacavir hypersensitivity available in Europe

The test confidently detects HLA-B*5701 to help decrease risk of abacavir hypersensitivity reaction

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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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Blood Screening Test That Offers Immediate Viral Discrimination for Three Major Viruses Receives CE Mark

cobas® TaqScreen MPX Test, v2.0[1] provides real-time results for HIV, HCV and HBV

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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’s test for Cytomegalovirus is approved in Europe

Test measures viral load of potentially deadly virus for transplant patients

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First Duplex Test for Parvovirus B19 and Hepatitis A Virus Now Available in the US

cobas® TaqScreen DPX Test can detect two important pathogens in human plasma.

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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 receives FDA approval for second-generation hepatitis B viral load test

Improved viral load testing with a sensitive and fully automated system

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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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FDA Approves New Roche Dual-PCR Target HIV-1 Test

First dual-PCR target viral load test approved for monitoring HIV patients receiving antiretroviral therapy

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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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FDA approves use of Roche test to screen source plasma for HIV, hepatitis B virus and hepatitis C virus

cobas® TaqScreen MPX Test is the most comprehensive – detects multiple viruses for increased plasma product safety

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Roche introduces new cobas p 630 Instrument and AMPLILINK 3.3 Series Software with CE Mark

New pre-analytical solution that integrates automated primary tube handling

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New Roche Dual Target HIV-1 Test Approved for Use in European Union

Extra confidence and security with an innovative Roche solution

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Improved Testing for Hepatitis B Virus from Roche

A sensitive and fully automated platform improves viral load testing in serum and plasma

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Roche receives FDA approval for Hepatitis C viral load test on its fully automated real-time PCR platform

Improved laboratory efficiencies and standardization to personalize patient care

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FDA Approves First Hepatitis B Viral Load Test

Another Roche first in TaqMan® real-time PCR testing for the diagnostic lab

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New Roche Chlamydia Test Approved for Use in European Union

Test offers more reliable detection of Chlamydia trachomatis, the most commonly reported sexually transmitted disease in Europe.

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Japanese Red Cross selects Roche as partner for nucleic acid screening of entire Japanese blood supply

Unique cobas test system for simultaneous detection of HIV and Hepatitis in donated blood Roche announced today that the Japanese Red Cross (JRC) has selected Roche as supplier for next-generation nucleic acid screening of the country’s 5 million annual blood …

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FDA Approves New Roche West Nile Virus Blood Screening Test

Automated test helps ensure safety of blood supply by detecting virus earlier in infection cycle. Roche Diagnostics announced that the US Food & Drug Administration (FDA) today approved its biologics license application for the company’s test for direct detection of …

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Highly sensitive and accurate Roche HIV-1 Test approved by FDA

Automated test enables faster results for doctors monitoring treatment response Roche announced today that the U.S. Food & Drug Administration (FDA) has approved its new HIV-1 test for diagnostic use in the United States. The highly accurate Cobas AmpliPrep/Cobas TaqMan …

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Roche Diagnostics Submits West Nile Virus Blood Screening Test to FDA

Automated test uses real-time PCR to detect West Nile Virus in donated blood & plasma Roche Diagnostics announced today that it has submitted its Biological License application for the cobas TaqScreen WNV Test to United States Food & Drug Administration …

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Roche Diagnostics Submits Hepatitis C Viral Load Monitoring Test to FDA

Test designed to give doctors highly accurate results and to improve workflow efficiency for labs Roche Diagnostics announced today that it has submitted its automated test for Hepatitis C viral load monitoring to the U.S. Food & Drug Administration (FDA) …

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