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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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Roche receives FDA approval for CMV viral load testing on cobas® 6800/8800 Systems

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® CMV (cytomegalovirus) test for use on the fully automated cobas® 6800 and cobas® 8800 Systems.

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cobas® CMV for the cobas® 6800/8800 Systems

Enhance the picture of CMV control with a standardized, CE/FDA-approved, real-time PCR viral-load test.

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Roche announces launch of cobas® HPV on the cobas® 6800/8800 Systems for cervical cancer screening in markets accepting the CE mark

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE-IVD launch of cobas® HPV for use on the cobas® 6800/8800 Systems for cervical cancer screening. Human Papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk.

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Roche receives FDA Emergency Use Authorization for Zika PCR test

Roche today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the LightMix® Zika rRT-PCR Test.

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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 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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Zika virus (ZIKV)

A total of 60 countries and territories were currently reporting continuing mosquito-borne transmission of the Zika virus as of June 1, 2016. 1

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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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Human papillomavirus (HPV)

Recent research has identified the Human papillomavirus as the cause of 99 percent of all cervical cancer.

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West Nile virus (WNV)

Although humans are not the primary hosts for WNV, they may become infected through a mosquito bite. Most infections are usually asymptomatic, however the virus can be transmitted through blood, tissue and organ donations.

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Varicella Zoster virus (VZV)

Varicella—commonly called “chickenpox”—occurs worldwide and affects nearly every person by mid-adulthood.

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Mycobacterium tuberculosis (MTB)

In 2014, 9.6 million people fell ill with tuberculosis, and 1.5 million died. The vast majority of deaths occur in low- and middle-income countries.1

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Influenza

Each year, approximately 20-30% of children and 5-10% of adults acquire an Influenza A or B infection.1

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Hepatitis C (HCV)

Approximately 130–150 million people globally have a chronic hepatitis C infection, with 3 to 4 million new infections occurring each year.1

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Hepatitis B (HBV)

An estimated 240 million people worldwide carry a chronic hepatitis B infection, and more than 780,000 die each year due to complications like cirrhosis and liver cancer.1

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Hepatitis A (HAV)

HAV has a global distribution and is transmitted via the oral-fecal route, primarily by close personal contact. Several genotypes and subtypes have been identified. Epidemics are common in developing countries, where sanitation standards are low.1-3

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Epstein-Barr virus (EBV)

EBV is associated with a wide range of benign and malignant diseases.

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Cytomegalovirus (CMV)

CMV is a very common viral infection which remains latent in an infected person’s body throughout their life.

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Human parvovirus B19 (B19V)

Parvovirus B19 screening is an important service provided by plasma centers worldwide.

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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® 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® 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® 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 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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LINEAR ARRAY® HPV Genotyping Test

Persistent HPV infection with specific high-risk HPV types is an indicator of high grade lesions (HSIL).1 HPV genotyping assays, may be used in cytology negative, HR-HPV-positive women over 30 in the same…

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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 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 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 CMV in markets accepting the CE mark

cobas® CMV assay offers unparalleled performance on the 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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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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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 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 Cytomegalovirus viral load test

First FDA-approved laboratory test for quantifying DNA of potentially deadly virus helps physicians manage organ transplant patients on antiviral therapy

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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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ATHENA Data Presented at International Papillomavirus Conference Support Use of Roche’s cobas® HPV Test in Primary Screening for Cervical Cancer

Data demonstrates the cobas® HPV Test, with its option of individual HPV 16 and 18 genotyping, provides additional risk stratification for high risk HPV-positive women. A separate study by Dutch HPV experts validates the cobas HPV Test for use in primary screening utilizing its ability to detect 14 high risk HPV types

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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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Pivotal Study Validates Roche’s cobas® HPV Test with HPV-16 and 18 Genotyping for Identifying Women at Highest Risk for Cervical Cancer

ATHENA study shows the cobas HPV Test advances the standard of care by providing valuable information on the risks associated with the genotypes which cause 70 percent of cervical cancer

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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 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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First Duplex Test for Parvovirus B19 and Hepatitis A Virus Increases Safety of Human Plasma and Plasma Products

cobas® TaqScreen DPX Test offers real-time discrimination in a single assay

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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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Preliminary Data from Roche ATHENA Cervical Cancer Trial Support Value of Human Papillomavirus Genotyping

Preliminary Data from Roche ATHENA Cervical Cancer Trial Support Value of Human Papillomavirus Genotyping

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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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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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FDA Accepts for Review Two Roche Diagnostics HPV Tests

Tests are designed to detect and genotype high-risk HPV types which, if present in persistent infections, can progress to cervical cancer Roche Diagnostics announced today that the United States (U.S.) Food & Drug Administration has accepted for review its applications …

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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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