FDA Approves Roche HPV Test for SurePath Collection Media

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Roche's Cobas HPV Test as a first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid, Roche announced today.

Becton Dickinson's SurePath preservative fluid is commonly used as a collection medium for Pap tests. The Cobas test is now approved for use as a primary screening test with SurePath and Hologic's ThinPrep PreservCyt Solution, the two liquid media used to collect samples for the vast majority of Pap or HPV tests in the US, Roche said.

The FDA approval, it added, means that the Cobas HPV Test is approved for all cervical cancer screening indications that are supported by professional society guidelines — primary screening in women 25 years of age and older, reflex testing of unclear Pap test results in women 21 and older, and cotesting with a Pap test in women 30 and older — with both SurePath and ThinPrep PreservCyt Solution.

Roche's test was introduced in 2011 and individually identifies the presence of the DNA of HPV genotypes 16 and 18, the two genotypes responsible for about 70 percent of all cervical cancer. It can also be used to report the 12 other high-risk HPV types as a combined result in one test from one patient sample.

Roche received the first FDA approval to use an HPV test for primary cervical cancer screening for the Cobas test in 2014. The test is approved for use in the US with the PCR-based Cobas 4800 platform.

"Before today, laboratories did not have an FDA-approved HPV test available that could cover all of the HPV screening options supported in professional guidelines and be used with both of the primary Pap test collection media," Ann Costello, head of Roche's tissue diagnostics business, said in a statement. "With this additional approval for the Cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types, so they can more easily provide the most appropriate options for their patients."