WASHINGTON, Calif., March 13 (UPI) -- An advisory committee to the U.S. government voted unanimously to recommend a HPV test as the first-line standard of care for cervical cancer screening.
The Medical Devices Advisory Committee Microbiology Panel to the U.S. Food and Drug Administration voted 13-0 Wednesday in Washington to recommend the cobas viral DNA test for HPV -- made by Roche Molecular Systems -- for cervical cancer screening. The committee said the benefits of the new tests outweighed the risks, Medpage reported.
The cobas test is currently approved as a follow-up assessment for women age 21 and older who have abnormal Pap smear tests, and as a co-test with the Pap smear to screen for the high-risk p16 and p18 HPV strains in women ages 30 to 65.
A proposal by Roche said women age 25 and older who tested positive for HPV16 or 18 would be given a colposcopy -- a diagnostic procedure to examine the cervix for further assessment.
Patients who tested negative for HPV16 or 18 but positive for the other high-risk strains would have a Pap smear to determine the need for colposcopy.
Both presentations by FDA staff and Roche depended on follow-up data from a 47,208-patient study.
The data showed using the primary cobas HPV test detected more women with disease, but required fewer women without disease to go to colposcopy, the FDA staff said.
