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Digene's papillomavirus test cleared in US:

This article was originally published in Clinica

Executive Summary

The FDA has given marketing clearance for Digene's Hybrid Capture II, a DNA-based test for the human papillomavirus (HPV) - the cause of almost all cervical cancer. Dr Attila Lorincz, scientific director of the Beltsville, Maryland-based company, said that the test: "detects up to 90% to 95% of high grade cervical disease. The Pap smear, on the other hand, may miss 20% to 30% of cervical cancers and their pre-malignant lesions." Studies in progress should reveal whether or not supplementing Pap smears with HPV testing not only prevents women with treatable disease being missed, but also allows smears to be done less frequently, thereby reducing the cost of screening.

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