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Originally published March 12, 2014 at 8:31 PM | Page modified March 13, 2014 at 6:56 AM

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FDA urges test option to Pap test to detect cervical cancer

A federal advisory committee recommended unanimously Wednesday that a test developed by Roche to detect the virus that causes cervical cancer be approved for use as a primary screening tool, with Pap testing used only on certain occasions as a backup.


The New York Times

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The Pap test, a ritual for women that has been the mainstay of cervical-cancer prevention for 60 years, may be about to play a less crucial role.

A federal advisory committee recommended unanimously Wednesday that a test developed by Roche to detect the virus that causes cervical cancer be approved for use as a primary screening tool, with Pap testing used only on certain occasions as a backup.

Testifying before the committee, which advises the Food and Drug Administration (FDA), Dr. Dorothy Rosenthal of Johns Hopkins University said deaths from cervical cancer in the United States had stopped declining and that there would be “a tremendous gain” by moving to the new test.

The Roche test detects the DNA of human papillomavirus, or HPV, which causes almost all cases of cervical cancer. Pap testing involves examining a cervical sample under the microscope looking for abnormalities.

Until now HPV testing has been used mainly as a follow-up test when the Pap results were ambiguous, or used jointly with Pap testing.

Wednesday’s 13-0 vote — by a committee mainly of academic pathologists, laboratory directors and gynecologists — would allow Roche’s test to be used alone as the initial test for women 25 and older. If the FDA agrees with its advisory committee and approves the new use of Roche’s test, it would become just another option, not a replacement for the older testing regimens.

Use as a primary screening tool could mean much wider sales of HPV tests.

Current U.S. guidelines recommend that women 30 to 65 undergo either co-testing with both HPV and Pap every five years, or Pap testing alone every three years. Women 21 to 30 are supposed to have Pap testing every three years.

The American Cancer Society estimates that about 12,360 new cases of invasive cervical cancer will be diagnosed in 2014 and about 4,020 women will die from the disease. Cervical cancer was once one of the most common causes of cancer death for American women. Then, between 1955 and 1992, the cervical-cancer death rate declined by almost 70 percent. It has remained stable since then.



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