Roche HPV Test Gets FDA Approval for Cervical Cancer Screen Using SurePath

The U.S. Food and Drug Administration approved Roche Holding AG’s cobas Human Papillomavirus, or HPV, test to be used as the first-line screening test for cervical cancer in women 25 and older using specimens collected in SurePath preservative fluid, a collection medium commonly used for Pap tests, the Swiss diagnostics and pharmaceuticals company said Monday.

Roche said the test is now approved for first-line screening with two most common collection media for Pap tests. With this FDA decision, the cobas HPV test is approved for all of the cervical cancer screening indications supported by professional society guidelines, the company said.

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.

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