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U.S. FDA Approves HPV Screening Test for Cervical Cancer (dateline August 8, 2003)

The U.S. Food and Drug Administration (FDA) recently approved the use of a screening test designed to detect the human papillomavirus (HPV), a sexually transmitted disease that can increase the risk of cervical cancer. HPV testing has previously been available to women who have received abnormal Pap test results but not for general screening purposes. The FDA approval makes the HPV test an option for all women 30 years of age in conjunction with their annual Pap tests.

The American Cancer Society estimates that in 2003, 13,000 new cases of invasive cervical cancer will be diagnosed in the United States and approximately 4,100 American women will die from the disease. Researchers estimate that non-invasive cervical cancer is nearly four times as likely as invasive cervical cancer. The International Agency for Research on Cancer estimates that nearly 380,000 women are diagnosed with cervical cancer worldwide each year. The number of cases and number of deaths from cervical cancer are higher in less developed countries where routine screening is not widespread.

The human papillomavirus (HPV) is a sexually transmitted disease. There are over 80 different strains of HPV, affecting more than 40 million Americans. While the majority of HPV strains do not pose health risks, a few strains increase the risk for cervical cancer. Annual Pap tests help screen women for cervical cancer and have contributed to a 75% decrease in cervical cancer deaths in the U.S since the mid-1950s.

Because some strains of HPV are linked to cervical cancer, the FDA recently approved the use of HPV testing for women who receive abnormal Pap test results. Approximately 50 million Pap smears are performed each year in the U.S., and 2 million of the tests produce unclear results (a result called ASCUS). However, physicians are not able to determine whether those abnormal results are harmless or signal pre-cancerous conditions. Before the approval of HPV testing, women with abnormal Pap results received follow up with either colposcopy (endoscopic viewing the cervix with magnification), with or without biopsy, or repeat Pap tests. The majority of women who undergo follow-up do not have pre-cancer or cancer and therefore these procedures turn out to be unnecessary.

Now, the FDA has approved HPV testing for all women 30 years of age and older in conjunction with yearly Pap tests. According to Digene Corporation, the company that makes the FDA approved HPV test, this screening could help reassure women with abnormal Pap tests and negative HPV tests that their short-term risk of cervical cancer is low.

According to Digene, approximately 50% of women with abnormal Pap test results (ASCUS) receive HPV testing as a follow up, and 90% of those women receive reimbursement from their health insurance for the HPV test. Digene says it is working with the FDA to obtain reimbursement for women who will now receive HPV screening tests.

HPV testing can also help alert physicians to women at risk for cervical cancer. "This [FDA} decision represents a major advancement in the fight against cervical cancer, offering women and their physicians the first objective screening measure of a woman’s risk for cervical cancer," said Evan Jones, Digene’s Chairman and Chief Executive Officer, in a news release. "We are extremely excited by the FDA’s decision. With our hc2 HR HPV Test, when used in conjunction with the Pap test, doctors can detect cervical disease and its precursors earlier than ever before."

The risk of cervical cancer is greater for women in their thirties, and therefore, the HPV screening test is not approved for younger women. Pap tests are available for these younger women and are still recommended for all women. Most physicians recommend that all women begin receiving yearly Pap tests and pelvic examinations at age 18 or when they become sexually active, whichever occurs earlier. Some physicians will not perform a Pap test each year if a woman has had three negative Pap tests in the course of three years. However, a yearly pelvic exam should be continued even if Pap tests are not given each year.

Nevertheless, cervical cancer remains relatively rare in the United States, where screening is widespread. Symptoms that may be associated with cervical cancer include unusual vaginal discharge, vaginal bleeding, or bleeding or pain during sexual intercourse.

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