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FDA Approves New Cervical Cancer Test

April 21, 2003
The US Food and Drug Administration (FDA) recently paved the way for close to 35 million American women aged 30 and above to receive enhanced screening for cervical cancer. The FDA has granted approval for the expanded use of an HPV test that had only previously been used as a follow-up test to an estimated 3 million abnormal Pap test results.

The test, the HC2 High-Risk HPV DNA test from Digene Corp. (Gaithersburg, Md.), does not test for cervical cancer, but for Human Papilloma virus (HPV) viruses, one of the most common forms of sexually transmitted diseases in both men and women.  In women, HPV can cause cells in the cervix to change and, can become cancerous if left untreated. It is approved for use in conjunction with the Pap test, a complete medical history, and an evaluation of other risk factors that will help your medical doctor to determine what other kind of follow-up is necessary.

For both the Pap and HPV tests, cells collected from the cervix are sent to a laboratory for analysis. But unlike the Pap test, which relies solely on the visual examination of these cells under a microscope, the new HPV test examines the genetic makeup of 13 high-risk strains of HPV to determine whether their presence is likely to lead to cancer. Experts believe that this new combination of screening for cervical cancer can can enhance the sensitivity in detecting cervical cancer close to 100%.

Although the prevalence of cervical cancer has decreased dramatically since the advent of the Pap test 50 years ago, the American Cancer Society estimates that in the United States, cervical cancer will be seen in approximately 12, 200 women, of which 4,000 will die. Scientists believe that, if detected earlier through enhanced screening, cervical cancer is avoidable and curable.
Related Pages
On this Site
Tests: Pap Test, HPV Test
Conditions: Cervical Cancer
Screening for Cervical Cancer: Teens, Young Adults, Adults, Adults (50 & up)

Elsewhere On The Web
U.S Food and Drug Administration – FDA News: FDA Approved Expanded Use of HPV Test
MEDLINEplus - Test, Vaccine Could Stop Cervical Cancer
National Cancer Institute - Human Papilloma Viruses and Cervical Cancer
American Cancer Society  - What are The Key Statistics for Cervical Cancer?
The Washington Post - Digene's Endurance Test
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This article last reviewed on April 21, 2003.
 
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