First HPV Test for Primary Cervical Cancer Receives FDA Approval

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First HPV Test for Primary Cervical Cancer Receives FDA Approval
First HPV Test for Primary Cervical Cancer Receives FDA Approval

The FDA has approved Roche's cobas HPV Test, the first human papillomavirus (HPV) DNA test for women ages >25 that can be used alone to help assess the need for additional diagnostic testing for cervical cancer. This test also can provide information about the patient's risk for developing cervical cancer in the future.

The cobas HPV Test was initially approved in 2011 for use in conjunction with or as follow-up to a Pap test. The FDA approval now expands use of the test as either a co-test or as a primary cervical cancer screening test.

RELATED: FDA Panel Recommends HPV Test That Could Replace Pap

The cobas HPV Test analyzes a sample of cervical cells and detects DNA from 14 high-risk HPV types—specifically HPV 16 and HPV 18. Women who test positive for HPV 16 or 18 should have a colposcopy. Women who test positive for >1 of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.

A study evaluated the use of the cobas HPV Test as a primary screening test for cervical cancer in over 40,000 women aged >25 years undergoing routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as those whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. Data comparisons showed that the cobas HPV Test was safe and effective for the new indication for use.

RELATED: Gynecologic Cancers Resource Center

For more information call (800) 526-1247 or visit

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