Roche Submits PMA Supplement To FDA For Cobas HPV Test

(RTTNews) - Roche Holding AG (RHHBY.PK), a biotechnology company, Monday said it has submitted a Pre-market Approval or PMA supplement to the US Food and Drug Administration or FDA seeking the addition of a cervical cancer primary screening indication for the cobas Human Papillomavirus or HPV Test. The cobas HPV Test is the only FDA approved test that provides pooled results for known high risk genotypes. In addition, the test can simultaneously provide individual results for the 2 highest risk genotypes, HPV 16 and HPV 18.

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 U.S.-based registration trial. ATHENA screened more than 47,000 women for cervical disease with Pap and HPV tests.