Well I don’t think you will find any women not liking this idea, self included here. The vote was 13 to 0 in favor of the DNA test. They did differ on the age to begin screening. Those that test positive would proceed to have a colposcopy.
Roche is the manufacturer of the test and of course the next question is cost. It will be interesting to see how this proceeds and of course there’s always smears for other diagnosis issues. BD
COLLEGE PARK, Md. -- An FDA advisory committee voted unanimously Wednesday to recommend that the Pap smear be replaced with a human papillomavirus (HPV) test as the first-line standard of care for cancer screening.
The FDA's Medical Devices Advisory Committee Microbiology Panel agreed by a vote of 13-0 in each of three successive votes that the cobas viral DNA test for HPV -- made by Roche Molecular Systems -- was safe and effective for cervical cancer screening, and that the benefits of the tests outweighed the risks.
The cobas test currently has approval as a follow-up assessment for women 21 and older who have abnormal Pap tests, and as a co-test with the Pap smear to screen for the high-risk p16 and p18 HPV strains in women 30 to 65. The test comprises genotyping for HPV16 and 18 and pooled assessment of 12 additional high-risk HPV strains.
Panelist Kenneth Noller, MD, of the American Board of Obstetrics and Gynecology, in Dallas, agreed that real-world use could differ from the protocol proposed by Roche. "I've been watching how people practice; if you're high-risk HPV positive you're going to get colposcopy," he said. "That doesn't necessarily mean it's bad -- it's what you do with the colposcopy."
The staff summary included the following performance characteristics of the cobas test versus cytology in the prospective cohort study:
- Sensitivity for ≥cervical intraepithelial neoplasia (CIN3) -58.26% versus 42.63%
- Positive predictive value -12.25% versus 6.47%
- Negative predictive value -0.42% versus 0.59%
- False-positive rate -4.09% versus 6.04%
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