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Roche's cervical cancer test receives US FDA approval for expanded use

Roche Holding AG said the U.S. Food and Drug Administration approved the expanded use of its cobas test as a primary screening for cervical cancer in women 25 and older.

The Switzerland-based pharmaceutical giant said its test is the only human papillomavirus, or HPV, test approved for use as a primary screening with the SurePath and ThinPrep PreservCyt Solution — the two types of liquid media used to collect samples for the vast majority of Pap and HPV tests in the U.S.

Roche said that following the FDA decision, the cobas HPV test is now approved for all cervical cancer screening uses that are supported by professional society guidelines.

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