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West Nile screening

This article was originally published in The Gray Sheet

Executive Summary

Gen-Probe plans to submit a BLA for its WNV blood screening assay after the 2004 mosquito season, VP-Regulatory, Quality & Government Affairs Glen Freiberg reports during a Q3 earnings call Oct. 30. The firm will use the time to "cost-effectively manufacture...and collect the clinical data" from three validation lots required for the BLA, Freiberg explains. Both Gen-Probe and Roche obtained IND status for WNV screens in late May. Gen-Probe reported WNV assay sales of $1.4 mil. for the quarter, with pricing restricted to IND cost recovery levels. Meanwhile, CBER is examining 2003 mosquito season data to determine an appropriate WNV viremia standard for approval of screens, Division of Emerging & Transfusion Transmitted Diseases Director Hira Nakhasi, PhD, notes at a recent FDA bioterrorism seminar...
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