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.