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FDA approves cobas human papillomavirus test to screen for cervical cancer risk

This approval offers women and physicians a new option for cervical cancer screening
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FDA has approved the cobas HPV Test to help healthcare professionals access the risk of developing cervical cancer in women 25 and older by examining cervical cells to detect DNA from 14 high-risk HPV types. Genital HPVs are a group of more than 40 related viruses, and are the “most common sexually transmitted infections, according to the CDC. Although most cases,of high-risk HPV infection goes away on its own without causing any health problems, approximately 10% of women infected with high-risk HPV (14 and up) develop a persistent infection which may put them at risk of cancer. Virtually all cervical cancers are caused by HPV infections. HPV 16 and HPV 18 have been found to be the cause of 70% of cervical cancers. Women who test positive for one or more of the 12 other high-risk HPV types would then need to have a Pap smear to determine the need for a colposcopy (an exam using a device that illuminates and magnifies the cervix so a physician can directly observe the cervical cells).

“This approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, Ph.D., 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.”

Although the Food and Drug Administration first approved the cobas HPV Test for use in conjunction with or as a follow-up to a Pap test (cell cytology), which examines cervical cells for changes that might become cervical cancer in 2011, this extension widens 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.

For more information, readers can contact the FDA at 888 Info-FDA.

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