FDA Approves First HPV Test for Primary Cervical Cancer Screening


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The U.S. Food and Drug Administration (FDA) approved the first human papillomavirus (HPV) DNA test that can be used as a primary cervical cancer screening test for women aged 25 years and older. The test also can provide information about the patient’s risk for developing cervical cancer in the future.

Using a sample of cervical cells, the cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPV.

Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy; women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Health-care professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, and current professional guidelines.

New Option for Screening

The FDA first approved the cobas HPV Test in 2011 for use in conjunction with or as a follow-up to a Pap test. Today’s approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test, however; it does not change current medical practice guidelines for cervical cancer screening. These guidelines are developed, reviewed, and modified by groups other than the FDA.

“Today’s approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women 25 years and older undergoing routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV Test results. Data from this study, which included 3 years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use. ■



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