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HPV Test Can Replace Pap, FDA Advisers Say

The test should be used as a first-line screening tool for cervical cancer, according to FDA advisers.

A test for the virus that causes cervical cancer can replace the annual Pap smear for many women, experts say.

The advisers to the Food and Drug Administration recommend that the agency allow the test’s maker to market it as a first-line screening tool for cervical cancer, which kills more than 3,000 U.S. women every year.

The test looks for evidence of human papillomavirus (HPV), which causes not only cervical cancer but cancer of the mouth, throat, penis and other areas. Women with evidence of active HPV infection could then be given a Pap test, which is examined for evidence of cancerous or precancerous cells.

“If approved, the cobas® HPV Test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the United States,” Roche, the company that makes the test, said in a statement.

Researchers found in 2011 that for women 30 and over, an HPV test is better than a Pap smear for predicting cervical cancer risk, and those who test negative on both can safely wait three years to be screened again.

HPV is extremely common. The Centers for Disease Control and Prevention estimates that 20 million Americans are currently infected with HPV. Another 6 million people become newly infected each year. For most, the virus clears their system on its own, but at least 50 percent of sexually active men and women are infected at some point in their lives. Some estimates range as high as 80 percent.

Cervical cancer kills more than 3,870 women a year in the United States and 300,000 globally. There are two commercial vaccines — Merck’s Gardasil and its rival, GlaxoSmithKline’s Cervarix.

The Pap test can find evidence of cervical cancer, which is very slow-growing, before it even becomes truly cancer. Doctors can remove the damaged cells.

But most cases are caused by HPV, and studies suggest that an HPV test is more accurate than a Pap.

The U.S. Preventive Services Task Force says most women can go as long as five years between cervical cancer screenings as long as they make sure to get both a Pap smear and an HPV test when they do get examined.