Roche recently announced it has submitted a Premarket Approval (PMA) supplement to the FDA seeking the addition of a cervical cancer primary screening indication for the cobas HPV Test. Approval of the expanded indication would mean the cobas HPV Test could be used as the first-line test rather than Pap cytology as part of a cervical cancer screening strategy. The filing includes new 3-year follow-up data from the ATHENA study, the landmark U.S.-based registration trial, including more than 47,000 women screened for cervical disease with Pap and human papillomavirus (HPV) tests.
The cobas HPV Test is the only FDA-approved test that provides pooled results for known high-risk genotypes and simultaneously provides individual results for the two highest-risk genotypes, HPV 16 and HPV 18. Data from the ATHENA study show strategies that incorporate high-risk HPV DNA testing with simultaneous detection of genotypes 16 and 18 as an initial screening test can detect more cervical disease than strategies that use Pap alone.
The cobas HPV Test received FDA approval in April 2011 to screen patients aged 21 years and older with abnormal Pap test results and to co-test with Pap in women aged 30 to 65 to assess the presence or absence of high-risk HPV genotypes. ■