In Brief: Digene
This article was originally published in The Gray Sheet
Executive Summary
Digene: Gains premarket approval application supplement approval to use its Hybrid Capture human papillomavirus (HPV) assay to test for HPV directly from Cytyc's PreservCyt sample vial -- which is currently used with the ThinPrep 2000 automated cervical sample preparation system. The approval allows a single cervical specimen preserved in PreservCyt solution to be microscopically evaluated via ThinPrep processing and then tested with the Hybrid Capture test if the screen is inconclusive. Digene entered a strategic alliance with Cytyc in October 1996 for joint marketing of Digene's Hybrid Capture HPV test and Cytyc's ThinPrep 2000 automated cervical sample preparation system ("The Gray Sheet" Oct. 14, I&W-7)...
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