Roche files with FDA for cobas HPV Test for Cervical Cancer primary screening

Roche 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 three-year follow-up data from the ATHENA study, Roche's landmark U.S.-based registration trial, including more than 47,000 women screened for cervical disease with Pap and HPV (Human Papillomavirus) tests. This shows 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 was approved by the FDA in 2011.