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The End of the Pap Test? FDA to Decide

How many women get both tests?

About half of women 30 and older who get a Pap test also get an HPV test, Saslow says. Not all doctors give both tests.

“New technologies and new protocols take a while to catch on,” Waxman says. If the FDA approves Roche’s HPV test as a primary test, he says, “my guess is ... it’s going to take a long time before we see a major shift in the way women are getting screened.”

Women who do get both tests might not realize it, because samples for the two tests are collected from the cervix at the same time.

How often would women be screened with a standalone HPV test, and at what age would they start?

While cervical cancer screening guidelines recommend that only women 30 and older get an HPV test, Roche proposes that its test be used in women as young as 25.

Their study followed women age 25 and older for 3 years. They received HPV and pap tests each year.

Saslow cautions it’s not clear whether women could go longer than 3 years that between normal HPV tests. Under current guidelines, women age 30 to 65 who get both tests can go 5 years between tests.

For the past 6 months, Saslow and representatives of other organizations involved in cervical cancer screening tests have been working on “interim guidance” for doctors and patients. They plan to have their guidelines ready by the time the FDA makes a decision.

Roche provided confidential research information to the group before it was made public at the FDA meeting, Saslow says. To help fill in the blanks, the working group is also looking at research done in Canada and Sweden and by Kaiser Permanente in Northern California.

In women tested only with the HPV test, what’s the next step if a high-risk type of the virus is found?

That depends. According to Roche’s application to the FDA, women whose tests show HPV 16 or 18, the highest-risk types, would then get a more thorough test called a colposcopy.

Women whose tests don’t show HPV 16 or 18 but do show one of the other high-risk HPV types would have a Pap test. If their Pap test is not normal, they would get a colposcopy.

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