FDA approves Roche Cobas HPV Test

The FDA has approved the cobas HPV (Human Papillomavirus) Test which identifies women at highest risk for developing cervical cancer. This test should help physicians make early, more accurate decisions about patient care, which may prevent many women from developing this deadly disease. The cobas HPV Test is 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 percent of cervical cancer cases, while simultaneously detecting 12 other high risk HPV genotypes. The approval was based on data from the ATHENA study involving more than 47,000 women in the US. Results demonstrated that 1 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.