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