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In Brief: Cytyc/Digene

This article was originally published in The Gray Sheet

Executive Summary

Cytyc/Digene: Firms plan to collaborate on a 385-patient, single-center study -- set to begin in coming weeks -- to assess combined use of Cytyc's ThinPrep 2000 automated cervical sample preparation system and Digene's Hybrid Capture assay to screen for human papilloma virus. The study is expected to take less than three months and will support separate premarket approval application supplements, which could be submitted to FDA by year-end, according to Cytyc. Using the two systems in tandem, clinicians would be able to employ a single cervical specimen preserved in Cytyc's Preservcyt solution both for standard microscopic evaluation and for use on the Hybrid Capture if the initial screen is inconclusive. The combined usage would eliminate the need to call patients back to take a second sample if the first screen is inconclusive and follow-up testing for HPV is required, Cytyc says...



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