The U.S. Food and Drug Administration has approved the first DNA test that serves as a primary screening for the human papillomavirus in women ages 25 and older.
The DNA test, cobas HPV Test manufactured by Pleasonton, Calif.-based Roche Molecular Systems, previously was approved for use in conjunction with or as a follow-up to a Pap smear. The new approval allows the cobas HPV Test to serve as either a co-test or a primary cervical cancer screening test.
The cobas HPV Test identifies DNA from 14 high-risk HPV types, with a special focus on HPV 16 and HPV 18, which together cause up to 70 percent of cervical cancers. Women who have positive results from the test should have a Pap test or a colposcopy, depending on the type of HPV testing positive.
"Today's approval offers women and physicians a new option for cervical cancer screening," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, in an FDA news release. "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."
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