Roche’s cobas HPV Test gets FDA approval for first-line primary screening for cervical cancer

Roche announced today that the U.S. Food and Drug Administration approved the cobas HPV (Human Papillomavirus) Test for use as a first-line primary screening test for cervical cancer in women 25 and older. The approval follows the March 12 unanimous recommendation from the Microbiology Devices Panel of the FDA's Medical Devices Advisory Committee, making the cobas HPV Test the first and only HPV test in the United States approved for first-line primary screening.

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