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The End of the Pap Test? FDA to Decide

By Rita Rubin
WebMD Health News

March 21, 2014 -- Is the Pap test going the way of car phones and Walkmans?

Pap tests are used to find early signs of cervical cancer. But over the past several years, studies from a number of countries have found that HPV tests are better than the Pap test at finding cervical cancer.

While HPV tests have been on the market for more than a decade, they are approved only for use along with the Pap test.

Earlier this month, an FDA advisory panel unanimously recommended that the FDA approve the HPV test made by the pharmaceutical company Roche as a first one to use for cervical cancer screening tests. The FDA often agrees with advisory panel recommendations, but it doesn’t have to.

Current cervical cancer screening guidelines, set by major organizations, say to test women every 3 years from age 21 to 65 with a Pap smear, or every 5 years from 30 to 65 with both a Pap test and an HPV test.

WebMD asked Debbie Saslow, PhD, director of breast and gynecologic cancer at the American Cancer Society, and Alan Waxman, MD, professor of obstetrics and gynecology at the University of New Mexico and a member of the FDA advisory panel, to help sort out the questions that remain.

How common is cervical cancer, and what does HPV have to do with it?

HPV is short for human papilloma virus, which can be spread through skin-to-skin contact. Certain types of HPV cause nearly all cervical cancers -- these are called "high risk" types. Other types of HPV cause genital warts.

After doctors began testing women with the Pap test in the 1940s, new cases of cervical cancer and deaths from it dropped dramatically. But the drop in cases has leveled off in recent years, particularly in women under 50.

The American Cancer Society estimates that in 2014, 12,360 U.S. women will be diagnosed with cervical cancer and 4,020 will die of it.

What is the Roche HPV test?

The FDA first approved Roche's HPV test in April 2011 for women ages 21 to 29 who have an abnormal Pap test, and as a “co-test” with the Pap test for women ages 30 to 65. The test is designed to find DNA from HPV 16 and HPV 18, the two types of HPV that cause 70% of cervical cancer cases worldwide. It also checks for DNA from 12 other high-risk types of HPV.

Roche's HPV test is not the only one. Other tests look for other combinations of high-risk HPV types.

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