FDA Approves HPV Test for Cervical Cancer Screening
Test specifically identifies HPV 16 and 18, as well as detecting 12 other types of high-risk HPVs
FRIDAY, April 25, 2014 (HealthDay News) -- -- The U.S. Food and Drug Administration has approved the first human papillomavirus (HPV) DNA test for women aged 25 years and older that can be used to assess the need for a woman to undergo additional diagnostic testing for cervical cancer. In addition, the test can provide information about a patient's future risk for developing cervical cancer.
The cobas HPV Test detects DNA from 14 high-risk HPV types using a sample of cervical cells. The test specifically identifies HPV 16 and 18, while detecting 12 other types of high-risk HPVs at the same time.
Based on results of the cobas HPV Test, women who test positive for HPV 16 or 18 should have a colposcopy, and women testing positive for at least one of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.
Other information should be used by health care professionals in conjunction with the cobas HPV Test results, including the patient's screening history and risk factors, as well as current professional guidelines.
The Cobas HPV Test's safety and effectiveness were evaluated in a study of more than 40,000 women 25 years and older undergoing routine cervical exams. The women had either a positive Pap test or cervical cells screening positive for HPV or negative test results. All underwent a colposcopy and cervical tissue biopsy. The biopsy results were compared to the Pap and cobas HPV Test results. Results from this study indicated that the cobas HPV Test was safe and effective for use as a primary screening tool for cervical cancer.
The cobas HPV Test is manufactured by Roche Molecular Systems Inc., based in Pleasanton, Calif.