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    Is HPV testing ready for ‘prime’ time in cervical cancer detection?

    Yes. Primary HPV testing is a potentially exciting new approach to cervical cancer screening


    On April 24, the United States Food and Drug Administration (FDA) approved the cobas human papillomavirus (HPV) DNA test for use as primary cervical cancer screening among women aged 25 years and older. This is the first time that an HPV test has been approved in the United States for use independent of a Pap test, although there are 4 FDA-approved tests for use as a reflex (ie, after an abnormal Pap test) or as a cotest (at the same time as a Pap test).1

    The FDA approval is limited to the cobas test within the screening framework presented to them, and the agency stated that it is the only test that is safe and effective as an alternative to cytology testing. This means that the FDA does not recommend the cobas test but has indicated that it is safe and no worse than the standard of care, ie, cytology/Pap screening or cotesting after age 30. National guideline committees so far have not issued recommendations about how to use the test, and we do not yet know whether the data presented to the FDA concerning the cobas test can be extrapolated to other HPV tests (which may not have been as rigorously studied), nor do we know the costs and benefits of different screening alternatives in different settings.


    Sarah Feldman, MD, MPH
    Dr. Feldman is Associate Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, Director of Ambulatory ...
    Aparna Kamat, MD
    Dr. Kamat is the Director of Gynecologic Oncology in the Department of Obstetrics and Gynecology at the Methodist Hospital, Houston, Texas.


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