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TriPath/Digene

This article was originally published in The Gray Sheet

Executive Summary

PMA supplement covering use of TriPath's SurePath liquid-based cytology specimen collection medium for cervical cancer screening with Digene's Hybrid Capture 2 HPV DNA test would allow HPV testing directly from SurePath specimens. Formerly called CytoRich, SurePath preservation vials and density reagents were approved for use on the AutoCyte PREP system, now called PrepStain, via PMA supplement in May 2001. Digene announced the filing for the Hybrid Capture 2, currently approved as a follow-up to borderline Pap test results, April 16...

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