Detects presence of high-risk strains of virus believed to cause disease
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 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.
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.
According to the U.S. Department of Health and Human Services, women should have a Pap test every two years starting at age 21. Women 30 and older who've 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.
Typically, an HPV infection clears up on its own and doesn't lead to health problems. But, about 10 percent of women infected with high-risk HPV develop a persistent infection that may put them at risk of cancer, the FDA said in the news release.
The FDA approval Thursday followed a unanimous vote by the agency's Medical Devices Advisory Committee Microbiology Panel in March that concluded the test was safe and effective as a first-line screen for cervical cancer.
Testifying before that expert panel, Dr. David Chelmow, chair of the department of obstetrics and gynecology at Virginia Commonwealth University School of Medicine, said that "cervical cancer screening has been a huge success in decreasing cervical cancer incidence and death."
Chelmow, representing the American College of Obstetricians and Gynecologists, added that "the college strongly supports further improving cervical cancer screening through the introduction of new paradigms such as HPV testing for primary screening. HPV testing as a primary screening method for cervical cancer is very promising, and appears effective for screening for cervical cancer."
Dr. Andrew Menzin, a gynecologic oncologist at North Shore University Hospital in Manhasset, N.Y., told HealthDay that "HPV testing has been a remarkable advance in cervical cancer screening."
Its greatest value is helping to decide whether a follow-up colposcopy is needed, he said. "The idea of reversing the order of testing is an approach to try to refine and minimize who [unnecessarily] goes on to colposcopy," he said.
Whether doctors will accept using an HPV test first instead of a Pap test will depend upon the clinical trial data supporting it and on doctors and patients being educated about it, Menzin said.
He noted that current guidelines still favor using the Pap test first, "but the guidelines continue to evolve."
There are two approved vaccines, Gardasil and Cervarix, that can protect against HPV. The U.S. Centers for Disease Control and Prevention recommends that all girls and boys be vaccinated between the ages of 9 and 11.
For more on cervical cancer, visit the American Cancer Society.
SOURCES: David Chelmow, M.D., chair, department of obstetrics and gynecology, Virginia Commonwealth University School of Medicine, Richmond; Andrew Menzin, M.D., gynecologic oncologist, North Shore University Hospital, Manhasset, N.Y.; April, 24, 2014, news release, U.S. Food and Drug Administration
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