FDA Approves HPV Test for Cervical Cancer
Detects presence of high-risk strains of virus believed to cause disease
WebMD News Archive
By Steven Reinberg
THURSDAY, April 24, 2014 (HealthDay News) -- 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 aged 25 and older.
"Today's approval offers women and physicians a new option for cervical cancer screening," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in an agency news release.
HPV, a sexually transmitted virus, is thought to cause 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 certain head and neck cancers.
Roche Molecular Systems Inc. makes the cobas HPV test. Women who test positive for the two high-risk HPV strains (16 and 18) would then be asked to undergo a colposcopy. This involves using a device that allows a doctor to get a clear view of the vulva, vagina and cervix and take a sample for further testing.
Women who don't have HPV 16 or 18 but have other high-risk types of the virus would have a Pap test to see if a colposcopy is needed, the FDA said.
One expert welcomed the test's approval.
Dr. Jill Rabin, head of urogynecology at Long Island Jewish Medical Center in New Hyde Park, N.Y., called the FDA approval "quite exciting."
But she tempered her enthusiasm with "some caveats," noting that "in many cases an HPV infection may resolve on its own." Rabin also stressed that "most -- but not all -- cervical cancers are caused by HPV," so the test is not foolproof.
The data the FDA reviewed for its decision came from a trial that included more than 47,000 women.
The FDA first approved the cobas HPV test in 2011, to be used with or as a follow-up to a Pap test. Thursday's approval expands the use of the test as either a "co-test" or as an initial screening test for cervical cancer. But, it doesn't change current guidelines for cervical cancer screening.