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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 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® 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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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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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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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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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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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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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 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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