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Digene's Hybrid Capture II

This article was originally published in The Gray Sheet

Executive Summary

Human papillomavirus test is more accurate than conventional Pap smear screening for identifying women with cervical disease, according to a study published in the Sept. 10 British Journal of Cancer and reported by Digene Sept. 13. The test was sufficiently sensitive to detect 95% of women with serious cervical disease while less than 5% of normal women tested positive, researchers found. In comparison, the Pap smear was able to detect only 79% of those with cervical disease. Conducted in the U.K. by the Imperial Cancer Research Fund, the study included 2,988 women over 35 who were given the HPV test and Pap screening simultaneously. The Hybrid Capture II was approved by FDA in March for use as an adjunct to the Pap smear for cervical cancer screening. Investigators suggest the findings support use of the test for primary screening

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