FDA Approves Two News HPV Tests For Women Age 30 And Older

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Mar 2009 - 4:00 PDT

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FDA has approved two new tests, developed by Bedford, Mass.-based Hologic, to screen for high-risk human papillomavirus types, the Boston Herald reports. Currently, there is only one FDA-approved test for HPV on the market, the Herald reports. Certain strains of HPV are a precursor to cervical cancer (McConville, Boston Herald, 3/14). According to U.S. News & World Report's "On Women," about 80% of women become infected with the sexually transmitted virus at some point in their lives, but in most cases, the virus clears on its own without causing problems (Kotz, U.S. News & World Report's "On Women," 3/17). According to Michael Gold, an associate professor at Vanderbilt University's gynecologic oncology division who reviewed data on the products, the new tests are more sensitive and specific than the existing test for HPV, resulting in "fewer false negatives, fewer false positives and fewer inadequate specimens." He added, "These new tests will further refine HPV testing and help us find women who are at the highest risk of developing cervical cancer."

Hologic's new Cervista HPV HR test is designed to detect 14 cervical cancer-causing strains of HPV. The other test, Cervista 16/18, is expected to help health care providers more easily identify patients with HPV types 16 and 18, which are the most common types of high-risk strains and together account for about 70% of cervical cancer cases in the U.S. (Boston Herald, 3/14). The new tests are approved for use in women age 30 and older with borderline cytology. According to FDA, the "Cervista HPV 16/18 test can be used together with cytology and the Cervista HPV HR test to assess risk of cervical disease." Differentiating between HPV types 16 and 18 gives health care providers more information about a patient's risk for developing cervical cancer, FDA said (FDA release, 3/13). The approval comes after clinical trials that included 4,000 women at 89 sites. Howard Doran, a senior vice president at Hologic, said medical laboratories will be using the new test in a few months (Boston Herald, 3/14).

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