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FDA approves HPV test for cervical cancer
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The FDA has approved a new human papillomavirus test that provides early and accurate information to identify women at greatest risk for developing cervical cancer, according to a press release.
The cobas HPV Test (Roche Molecular Systems) is a qualitative in-vitro test for the detection of HPV in patient specimens. The test was designed to provide rapid analysis of screening tests for HPV infections and offer walk-away results by performing up to 282 tests in less than 12 hours, according to the press release.
It is the only FDA-approved cervical cancer screening test that individually identifies HPV types 16 and 18, while concurrently testing for 12 other high-risk HPV genotypes.
Approval is based on results of the ATHENA study, which revealed that 1 in 10 women aged 30 years or older who tested positive for HPV 16 and/or 18 by the cobas test actually had cervical pre-cancer, even though their Pap test results were normal.
This method bests the Pap smear alone, according to Mark H. Stoler, MD, professor and associate director of Surgical Pathology and Cytopathology at the University of Virginia Health System. “Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the two highest risk types, HPV 16 and 18 can provide predictive information about a woman’s risk for having cervical pre-cancer or cancer,” Stoler said in the release. “The cobas HPV Test provides physicians with a validated tool that helps them make early and more informed decisions regarding patient care.”
The test is now available in the US and all countries accepting a CE mark.
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