FDA widens approval of Roche cobas HPV test to new sample media

The test's screening indications include primary testing in women 25 and older, follow-up testing in women 21 and older, and Pap co-testing in women over 30. (Roche)

The FDA approved Roche’s cobas HPV test for first-line screening of cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid, commonly used in Pap tests.

The decision greenlights the test’s use across all cervical screening indications supported by professional society guidelines—in both of the types of liquid media that are used to collect the vast majority samples for Pap or human papillomavirus tests performed in the U.S.: ThinPrep PreservCyt Solution and, now, SurePath, according to Roche.


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Those cancer screening indications include primary testing in women 25 and older, follow-up testing of unclear results in women 21 and older, and co-testing with a Pap test in women over 30.

The cobas HPV test received its first FDA approval for first-line cervical cancer screening, without an accompanying Pap test, in 2014.

"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 Tissue Diagnostics, said in a statement.

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"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," Costello said.