FDA approves HPV test for cervical cancer screening

FDA NEWS RELEASE – April 24, 2014 – The FDA today expanded its approval of a DNA test as a standalone screen for the strains of virus that cause cervical cancer. The cobas HPV Test had previously been approved as a co-test along with a Pap test as a primary screening test for cervical cancer. The expanded approval was based on research data gathered from more than 40,000 women 25 years and older undergoing routine cervical exams involving either the Pap or HPV test and biopsy. After three years of follow-up, women who went to colposcopy showed that the cobas HPV Test by itself is safe and effective for cervical cancer screening use.

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