FDA approves DNA-based HPV test over women's groups' protest

The first human papillomavirus DNA test to screen women for cervical cancer was approved Thursday by the U.S. Food and Drug Administration. The stand-alone test can be used to assess whether women need to undergo additional testing and their risk of developing cervical cancer in the future.

HPV is the most common sexually transmitted infection, according to the Centers for Disease Control and Prevention. There are about 40 types of genital HPV, and high-risk types can cause cellular changes in the cervix that lead to cervical cancer. The cobas HPV Test from Roche Molecular Systems, approved for women 25 and older, detects DNA of HPV types 16 and 18, which are associated with 70% of the two most common types of cervical cancers, the FDA said.

The test can also detect 12 other high-risk types. Women testing positive for one or more of the 12 other high-risk HPVs would need to undergo a Pap test to determine if a colposcopy is needed.

“Today's approval offers women and physicians a new option for cervical-cancer screening,” said Alberto Gutierrez, director of the office of in vitro diagnostics and radiological health at the FDA Center for Devices and Radiological Health. A Roche study of more than 40,000 women, which included three years of follow-up, supported approval of the test, the FDA said.

Several organizations, however, argued that there were design problems with the clinical trial and that approval could lead to confusion.

In an April 14 letter to FDA Commissioner Dr. Margaret Hamburg, the organizations warned the tool is “not proven to work in a large U.S. population” and “could potentially replace the safe and effective, well-established screening tool and regimen that has prevented cervical cancer successfully in the U.S.”

They also argued the test is not supported by any evidence-based U.S. guidelines. The letter was signed by 17 organizations, including the American Medical Women's Association, Our Bodies Ourselves, Consumers Union and the National Physicians Alliance.

The FDA said the approval extends use of the test as either a co-test or as a primary cervical-cancer screening test, but does not change current medical practice guidelines for cervical-cancer screening.

Current guidelines recommend women have a Pap test every three years staring at age 21. Women with certain risk factors may need more frequent testing. It can take years for a persistent infection with a high-risk HPV type to develop into cancer; about 10% of women with high-risk HPV on their cervix will develop the long-lasting infections that put them at risk for cervical cancer.

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