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Roche HPV Test Cleared by FDA

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Roche announced today the clearance of its cobas HPV test by the US Food and Drug Administration.

The test, the company said, identifies women who are at greatest risk for developing cervical cancer, and is the only cervical cancer screening test approved by the FDA that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing.

HPV 16 and 18 are the two highest-risk HPV genotypes and are responsible for more than 70 percent of cervical cancer cases, Roche said, and added that in addition to identifying genotypes for 16 and 18, the cobas HPV Test simultaneously detects 12 other high-risk HPV genotypes.

Current guidelines for screening allow for either cytology alone or cytology with HPV testing to determine cervical cancer risk. HPV testing, and in particular 16 and 18 genotyping, identifies more women at risk for cervical cancer earlier than Pap cytology testing by itself.

In the US, 55 million Pap smears are done each year.

Clearance from FDA was based on data from its Athena study of more than 47,000 women in the US, Roche said. Data from the study show that 10 percent of women age 30 and older who tested positive for HPV 16 and/or 18 by the cobas HPV Test had cervical pre-cancer, although Pap smears indicated normal results.

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