Procleix WNV approval
This article was originally published in The Gray Sheet
Executive Summary
FDA announces approval of the Procleix West Nile Virus assay biologic license application Dec. 1. The Gen-Probe test will be marketed by Chiron. Since 2003, the assay has been used for WNV screening by facilities, including the American Red Cross, under an investigational new drug application. The test will now be offered at commercial pricing levels, instead of at cost-recovery levels, Chiron says. Although the assay is approved for use with the Procleix enhanced semi-automated system, the firms are seeking clearance for the fully automated Tigris system, which can handle individual donor screening in areas that have reached an infection threshold when pooled sample testing is insufficient...