The U.S. Food and Drug Administration advisory panel voted unanimously on Wednesday that a new HPV test can be used instead of a Pap smear to detect cervical cancer during the first steps of screening.
On three separate occasions, the panel voted 13-0 in favor of the safe and effective HPV option. The FDA does not have to, but usually does, follow their recommendations. The agency's Medical Devices Advisory Committee Microbiology Panel determined that the cobas HPV (human papillomavirus) test, made by Roche Molecular Systems, was suitable for a first-line screen for cervical cancer.
HPV is a sexually transmitted virus that is considered the cause of most cervical cancers, especially its strains HPV 16 and 18.
It works as a diagnostic tool as women who test positive for the HPV 16 and 18 types are then asked to undergo colposcopy, in which doctors can get a clear sample that will allow further testing. Women who do not exhibit HPV 16 or 18 but test positive for other high-risk strains would then have a Pap test to see if a colposcopy was needed.
This first-step screening is important, Dr. David Chelmow notes, because "cervical cancer screening has been a huge success in decreasing cervical cancer incidence and death," he testified to the panel, according to CBS News.
Currently, the cobas HPV test is approved for use among women aged 21 and older who have already received an abnormal Pap test. It is also approved as an additional screening method to a standard Pap test in women aged 30 to 65.
Gardasil and Cervarix are two approved vaccines that can help protect against HPV, and the Centers for Disease Control and Prevention recommend that all girls and boys start getting vaccinated at ages 9 to 11.
