Human Papillomavirus (Screening)

PMA Supplement Submitted for Next Generation Hybrid Capture HPV Test

Published in Women's Health Weekly, October 20th, 1997

Digene Corporation, Beltsville, Maryland, announced that it has submitted a Premarket Approval Application supplement to the U.S. Food and Drug Administration (FDA) for its Hybrid Capture II HPV DNA test.

The new Digene HPV Test is based on the company's Hybrid Capture II technology, which permits simultaneous testing of multiple samples from a single 96-well microtiter plate and is designed to be more efficient, less expensive, and easier to use than Hybrid Capture I, the company's first generation detection technology. Digene's Hybrid Capture I HPV test is the only FDA-approved test for the detection of human papillomavirus (HPV), the cause of essentially all...

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Source: Women's Health Weekly (1997-10-20)

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