Roche' Cobas HPV Test Gets FDA Approval For First-line Cervical Cancer Screening

(RTTNews) - Roche (RHHBY) said that it has received U.S. Food and Drug Administration approval for the cobas HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid, a collection medium commonly used for Pap tests.

The Roche test is now the only Human Papillomavirus (HPV) test approved for use as a primary (first-line) screening test with both SurePath and ThinPrep PreservCyt Solution, the two types of liquid media used to collect samples for the vast majority of Pap or HPV tests in the U.S.

With this FDA decision, the cobas HPV Test is now approved for all of the cervical cancer screening indications that are supported by professional society guidelines—primary screening in women 25 and older, reflex (follow-up) testing of unclear Pap test results in women 21 and older and co-testing with a Pap test in women 30 and older—with both of the primary collection media types.