Published March 13, 2014
For decades, Pap smears have been the first line of defense in screening women against cervical cancer. But now, an FDA committee has voted unanimously to replace the Pap smear with a DNA test designed to screen for human papilloma virus (HPV), MedPage Today reported.
The cobas viral DNA test, manufactured by Roche Molecular Systems, detects for the presence of HPV 16 and 18 – the two strains that are responsible for the majority of cervical cancer cases – as well as for other high risk strains.
Currently, the FDA recommends co-testing (using both Roche’s HPV test and Pap tests) for all women ages 30 to 65 every three years, or Pap testing alone every three years. For women ages 21 to 30, the FDA recommends only Pap testing every three years.
Based on the new guidelines approved by the committee, all women over the age of 25 would be tested using only the HPV DNA test as their primary form of screening. Women ages 25 and older who test positive for HPV 16 or 18 would then undergo a colposcopy – a test that can more closely detect for cervical abnormalities.
Women who test negative for HPV 16 or 18 but positive for other high-risk strains of HPV would undergo a Pap test in order to determine if a colposcopy is necessary, according to Roche’s guidelines.
“The data show that the proposed primary screening indication for the cobas HPV test detects more women with disease and requires fewer women without disease to go to colposcopy than cytology alone,” the FDA panel said in its recommendation.
Some experts expressed concern about lowering the age at which women should be tested for HPV 16 or 18 from 30 to 25, while others saw it as an opportunity to catch abnormalities well before they can progress into cancer.
"Now we have the opportunity to identify women earlier, and to me that's compelling," said FDA panel member Dr. Kimberly Hanson, of the University of Utah and ARUP Laboratories in Salt Lake City. "Although colposcopy is invasive and can be anxiety-provoking, it's really very safe, so I think I'm leaning toward earlier screening."
Though the FDA does not have to comply with the panel’s recommendation, it does so in most cases, according to MedPage Today.