Roche has announced that it has received U.S. Food and Drug Administration (FDA) 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.
The cobas HPV Test, introduced in 2011, helps healthcare providers identify women at risk for cervical cancer by individually identifying the presence of the DNA of HPV genotypes 16 and 18—the two genotypes responsible for about 70 percent of all cervical cancer—and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. Roche received the first FDA approval to use an HPV test for primary cervical cancer screening (without an accompanying Pap test) for the cobas HPV Test in 2014.
Ann Costello, Head of Roche Tissue Diagnostics said, “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. 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.”