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FDA Experts Debate Timing of Pap Test

Wednesday, March 12, 2014 (Last Updated: 03/13/2014)

WEDNESDAY, March 12, 2014 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel is considering whether to delay the Pap test and use an human papillomavirus (HPV) test as a first step in cervical cancer screening. Specifically, the agency's Medical Devices Advisory Committee Microbiology Panel is being asked to evaluate the cobas HPV test made by Roche Molecular Systems.

Roche is looking for the FDA to approve its HPV test as a first-line diagnostic tool. Women who test positive for the two high-risk HPV strains would then be asked to undergo colposcopy. In addition, women who did not have HPV 16 or 18 but had other high-risk types of the virus would then have a Pap test to see if a colposcopy was needed. The data the committee is looking at comes from a trial called ATHENA that included more than 47,000 women.

For its part, the FDA is looking for the panel's recommendation as to whether the HPV test does the job for which it is intended, and performs it in a safe manner. The agency is also asking the panel whether any risk associated with the test outweighs its benefits. Although the FDA is not required to follow its advisory panels' recommendations, it usually does so. Currently, the cobas HPV test is approved for use among women 21 and older who have already received an abnormal Pap test. It is also approved as an add-on to a standard Pap test in women 30 to 65. According to Roche, the cobas HPV test is able to screen for a variety of high-risk strains of HPV.

Representing the American College of Obstetricians and Gynecologists, David Chelmow, M.D., of the Virginia Commonwealth University School of Medicine in Richmond, told HealthDay that "the College strongly supports further improving cervical cancer screening through the introduction of new paradigms such as HPV testing for primary screening. HPV testing as a primary screening method for cervical cancer is very promising, and appears effective for screening for cervical cancer."

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Specialties Hematology & Oncology
Pharmacy

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