FDA Approves New Cervical Cancer Screening Test Test For HPV Now Combined With Pap Smear
4/17/2003 The American Cancer Society The Food and Drug Administration has approved a new screening test for cervical cancer that could help distinguish women at increased risk from those at very low risk of developing the disease. Women over age 30 can now receive a test for human papilloma virus, or HPV, at the same time they receive a Pap test. The HPV test, manufactured by Digene Corp. of Gaithersburg, Maryland, is already approved to detect HPV in women with abnormal Pap smears, but until now, it was not approved for screening purposes, before results of the Pap test were known. Since March, 2000, the test has been used for women whose Pap tests show mild abnormalities that can’t be readily explained, a condition referred to as Atypical Squamous Cells of Unknown Origin, or ASC-US. Until then, such women had to undergo repeated Pap smears every few months in hopes of determining the nature of the abnormal cells – whether they might develop into precancerous lesions or clear up on their own. In some cases, a colposcopy – an examination of the cervix with magnifying binoculars - was used to select areas of the cervix to biopsy, to determine whether the cells were dangerous. Women with ASC-US Pap results who have negative HPV test results could be reassured that their short term risk of developing cervical cancer was very low, and that they could safely return to the usual screening schedule. HPV is a family of more than 100 extremely [...]