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NCI HPV Trial Data Re-Evaluated By Digene To Support PMA Supplement

This article was originally published in The Gray Sheet

Executive Summary

Digene will reanalyze clinical data and specimens from a 23,702-patient trial in Portland, Oregon, prior to seeking a primary screening indication for its HybridCapture 2 HPV test. The Gaithersburg, Maryland firm expects to file a PMA supplement by year-end.

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