FDA panel unanimous on HPV test as Pap replacement
US Food and Drug Administration
(HealthDay News) -- A U.S. Food and Drug Administration advisory panel voted unanimously on Wednesday that a new human papillomavirus (HPV) test could be used before or instead of the Pap smear as a first step in cervical cancer screening.
In three separate 13-0 votes, the agency's Medical Devices Advisory Committee Microbiology Panel concluded that the cobas HPV test, made by Roche Molecular Systems, is safe and effective as a first-line screen for cervical cancer. Although the FDA is not required to follow the recommendations of its advisory panels, it typically does.
Andrew Menzin, M.D., a gynecologic oncologist at North Shore University Hospital in Manhasset, N.Y., told HealthDay that "HPV testing has been a remarkable advance in cervical cancer screening." Its greatest value is helping to decide whether a follow-up colposcopy is needed, he said.
In addition, he told HealthDay that "the idea of reversing the order of testing is an approach to try to refine and minimize who [unnecessarily] goes on to colposcopy." Whether doctors will accept using an HPV test first instead of a Pap test will depend upon the clinical trial data supporting it and on doctors and patients being educated about it, Menzin believes. He noted that current guidelines still favor using the Pap test first, "but the guidelines continue to evolve."