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The Food and Drug Administration has approved the use of the use of the cobas HPV Test to identify women at highest risk for developing cervical cancer.


The test, made by Roche, is now the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing. It individually identifies genotypes 16 and 18, the two highest-risk HPV genotypes responsible for more than 70% of cervical cancer cases, while simultaneously detecting 12 other high-risk HPV genotypes.


The approval was based on data from the "ATHENA" study involving some 47,000 women in the United States, which showed that one in 10 women, age 30 and older, who tested positive for HPV 16 and/or 18 by the cobas HPV Test actually had cervical pre-cancer even though they showed normal results with the Pap test.


"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," Mark H. Stoler, MD, Professor and Associate Director of Surgical Pathology and Cytopathology, at the University of Virginia Health System, said in a news release. "The cobas HPV Test provides physicians with a validated tool that helps them make early and more informed decisions regarding patient care."