According to the American Cancer Society, in 2003, 12,200 women will be diagnosed with cervical cancer and 4,100 will die from the disease. With proper screening, cervical cancer is avoidable and, if caught early, curable.
March 12, 2010
FROM THE FDA- The Food and Drug Administration (FDA) today approved expanded use of a laboratory test to detect the presence in women of human papillomavirus (HPV), one of the most common sexually transmitted infections. There are more than 100 types of HPVs. The test, the HC2 High-Risk HPV DNA Test, manufactured by Digene Corp., of Gaithersburg, Md., can identify 13 of the high-risk types associated with the development of cervical cancer.
The HPV DNA test does not test for cancer, but for the HPV viruses that can cause cell changes in the cervix. If left untreated, these changes can eventually lead to cancer in some women.FDA initially approved the HPV DNA test in March 2000 for testing women who had abnormal Pap test results to determine whether they needed to be referred for further examination. The new indication allows the test to be used for screening, in conjunction with the Pap test, of women over age 30 for HPV infection. It should be used along with the Pap test, a complete medical history and an evaluation of other risk factors to help physicians determine what kind of follow-up is necessary.Knowing whether or not a woman is infected with high-risk HPV is added information that will help physicians detect and treat early cell changes that might eventually lead to cervical cancer, said FDA Commissioner Mark B. McClellan, M.D., Ph.D. FDA is committed to bringing safe and effective new technologies to the market quickly.