FDA OKs Expanded HPV Test for Women
Test Detects High-Risk Viruses That Can Cause Cervical Cancer
April 2, 2003 -- Like the Pap test, a test for HPV -- human papillomavirus -- could soon be an annual event for women over age 30. The FDA has expanded its approval of a new test for this virus, which causes most cases of cervical cancer.
Cervical cancer will strike over 12,000 American women this year and kill 4,100, according to the American Cancer Society. It usually grows slowly, so regular Pap smears can catch it early -- often, when cells are just beginning to turn cancerous. Early detection can help doctors cure or even prevent cervical cancer.
However, Pap tests are often inconclusive, showing abnormal cells that may or may not be precancerous.
HPV -- which has long been linked with cervical cancer -- is one of the most common sexually transmitted infections, says an FDA statement, with an estimated 20% of the sexually active U.S. population infected with HPV at any one time.
Most women who become infected with HPV are able to naturally fight off the virus and suffer no apparent long-term health problems. But a few women develop a persistent infection that can eventually lead to pre-cancerous changes in the cervix.
Three years ago, the FDA approved a limited use of the HC2 High-Risk HPV DNA Test, manufactured by the Digene Corp., of Gaithersburg, Md., for women who had abnormal Pap test results. The HPV test results helped determine whether the women needed to be referred to a specialist for further examination.
This expanded FDA approval allows the test to be used for screening of all women over age 30. Along with the Pap test, a complete medical history, and an evaluation of other risk factors, it will help doctors determine if any kind of follow-up is necessary.
In the HPV test -- like the Pap test -- the doctor takes a swab of cells from the cervix. The cell swab is then sent to a laboratory for analysis. While there are more than 100 types of HPV, this test can identify the DNA of 13 high-risk types even before there are any visible changes to the cells on the cervix.