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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
Date:2/24/2011

missed by the Pap test, underscoring the limitations of cervical cancer screening with the Pap test alone.

"Arming more clinicians with HPV testing that has HPV-16 and HPV-18 genotyping will bring us one step closer to eradicating cervical cancer," said Paul Brown, Head of Roche Molecular Systems. "Results of the ATHENA study underscore the potential for a state-of-the-art diagnostic test to specifically identify women at highest risk for cervical disease."

About the Roche ATHENA Clinical Trial

The Roche ATHENA study for the cobas HPV Test is the largest U.S.-based registration study for cervical cancer screening, including more than 47,000 women. The study is designed to answer current medical and scientific questions about the importance of testing for high-risk HPV genotypes in cervical cancer screening and to provide clinical information about the specific HPV genotypes that place women at highest risk for developing cervical cancer. Results show the cobas HPV Test is comparable to the current standard of testing. Results also demonstrated that 1 in 10 women, age 30-years and older, who tested positive for HPV - 16 and/or 18 by the cobas HPV Test had cervical pre-cancer, although their Pap test was normal.  

About the cobas HPV Test

As demonstrated in the ATHENA trial, Roche's cobas HPV Test is the only HPV test under investigation in the U.S. that simultaneously detects 12 high-risk HPV types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) as a pooled result, as well as HPV genotypes 16 and 18 individually. Roche launched the cobas HPV Test in countries that accept CE Mark in 2009. The test is currently under review and pending Pre-Market Approval (PMA) by the U.S. Food and Drug Administration (FDA). The test is not currently available in the United States.

About Human Papillomavirus and Cervical Cancer

Persistent infection with human p
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SOURCE Roche Diagnostics
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