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FDA Approves Cancer Detection Test For HPV

The U.S. Food and Drug Administration on Thursday approved a human papillomavirus (HPV) test as a first step in cervical cancer screening for women ages 25 and older.

HPV, a sexually transmitted virus, is the cause of the majority of cervical cancers. Certain strains, such as HPV 16 and 18, are most strongly tied to these tumors. The virus also causes genital warts in both men and women and some head and neck cancers.

The two strains of the virus are responsible for about 70 percent of all cases.

Roche Molecular Systems Inc. makes the cobas HPV test, which was approved. It looks for HPV DNA in cervical cells. The test can detect genetic material from 14 high-risk HPV types including the HPV 16 and 18.

Currently, the most common form of cervical cancer screening is the Papanicolaou (Pap) test, also referred to as a cervical smear test. This involves a doctor or nurse scraping cells from the opening of the patient’s cervix, before sending them to a lab to be assessed for abnormalities.

“[This] approval offers women and physicians a new option for cervical cancer screening. 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,” says Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a news release.

This test was previously approved by FDA in 2011 to be used in conjunction with pap tests, but it has since then proven to be safe, effective, and accurate.

The data the FDA reviewed for its decision came from a trial that included more than 47,000 women.

Thursday’s approval expands the use of the test as either a “co-test” or as an initial screening test for cervical cancer.

The U.S. Department of Health and Human Services recommends that women should have a Pap test every two years starting at age 21. Women aged 30 and older who have had three normal Pap tests in a row, can now have one every three years. Women older than 65 may be able to stop having Pap tests, but should discuss the matter first with their doctor.

S.C. Rhyne is a blogger and novelist in New York City. Follow the author on Twitter @ReporterandGirl, and visit her website at

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