FDA approves new cervical cancer test

By Advocate.com Editors

Originally published on Advocate.com April 02 2003 12:00 AM ET

The Food and Drug Administration on Monday approved Digene's dual DNA and Pap test as a primary screening tool for cervical cancer in women over age 30, The Washington Post reports. The test, which combines the standard Pap test with a DNA test that screens for 13 strains of the sexually transmitted human papillomavirus linked with the development of more than 90% of all cervical cancer cases, had previously been available only to women who had abnormal Pap results. Women who have an abnormal Pap test and who test positive for one of the HPV stains have a 1-in-15 chance of developing cervical cancer.

"If you just rely on a Pap, the sensitivity may be 70% or 80%," said Diane Davey, a professor of pathology at the University of Kentucky Chandler Medical Center. "With HPV testing, it's probably in the range of 85% or 95%. But if you put them together, the combination is close to 100%."

According to preliminary guidelines released by the American Cancer Society, women who test negative using Digene's test may not have to be tested again for up to three years. The test costs about $50 to $60 and may not immediately be covered by all insurers. Digene officials say they plan to mount an aggressive campaign to urge health insurers to cover the new test and to educate health care providers on how to accurately interpret its results. The American Cancer Society is expected later in April to revise its cervical cancer screening guidelines to include use of the newly approved test.