Currently Roche’s cobas DNA test is only approved as a follow-up to an abnormal Pap smear for women ages 21 and over and as a co-test with a Pap smear to screen for the p16 and p18 HPV strains in women ages 30 to 65, according to the report.
Roche proposed women 25 and older who test positive for p16 or p18 would next directly receive a colposcopy. Women who test negative for the two strains but positive for other high-risk strains would then have a Pap test to see if a colposcopy is needed, according to the report.
Roche presented data from a study observing more than 47,000 patients testing its cobas test. The study found 11 percent of women between ages 25 and 29 tested positive with Roche’s cobas test, while only 7.28 percent of women of the same age group tested positive for the high-strain viruses using cytology, analyzing single cells or small groups of cells, alone.
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