The U.S. Food and Drug Administration has approved Roche’s cobas HPV Test — the first diagnostic to be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.
SurePath is an FDA-approved liquid collection fluid that’s frequently used for Pap tests. But until this latest approval, no human papillomavirus (HPV) test had been approved to be used with the fluid, the FDA said in a news release.
HPV strains account for some 70 percent of cervical cancers globally. The U.S. National Cancer Institute estimates there will be nearly 13,000 new cases of cervical cancer detected this year, and the disease will cause more than 4,100 deaths.
The Swiss drugmaker Roche in 2012 warned that using cervical cells in SurePath fluid with an existing HPV test could produce false-negative results, the FDA said. This could have led to lack of treatment and cervical cancer progression among women who obtained false-negatives.
Learn more about this approval from the FDA.
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