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FDA Panel Says HPV Test Could Replace Pap Smear

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An FDA committee has voted unanimously to make a DNA test designed to screen for human papilloma virus (HPV) the primary cervical cancer screening tool for women aged 25 years and older, Fox News reported.

The health regulator's Medical Devices Advisory Committee's Microbiology Devices Panel determined that the benefits of Roche Molecular System's cobas HPV test outweigh the risks, Fox News reported.  The test detects for the presence of HPV 16 and 18 - the two strains that are responsible for the majority of cervical cancer cases - as well as for other high risk strains.

The test was clinically validated by a three-year ATHENA trial.

"The data show that the proposed primary screening indication for the cobas HPV test detects more women with disease and requires fewer women without disease to go to colposcopy than cytology alone," the FDA panel said in its recommendation.

HPV 16 and 18 are the highest-risk genotypes responsible for 70% of cervical cancer cases.

The new guidelines approved by the committees say that all women over the age of 25 will be tested using only the HPV DNA test as their primary form of screening. Women ages 25 and older who test positive for HPV 16 or 18 would then undergo a colposcopy - a test that can more closely detect for cervical abnormalities.

The health regulator currently recommends co-testing (using both Roche's HPV test and Pap tests) for all women ages 30 to 65 every three years, or Pap testing alone for every three years.  For women ages 21 to 30, the FDA recommends only Pap testing every three years, Fox News reported.

"Now we have the opportunity to identify women earlier, and to me that's compelling," FDA panel member Dr. Kimberly Hanson,  of the University of Utah and ARUP Laboratories in Salt Lake City, told Fox News. "Although colposcopy is invasive and can be anxiety-provoking, it's really very safe, so I think I'm leaning toward earlier screening."

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