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Chiron platelet testing

This article was originally published in The Gray Sheet

Executive Summary

Firm expects 510(k) clearance for platelet bacteria detection within 12-18 months, following Jan. 5 licensure of the technology from Canadian firm Infectio Diagnostic. Chiron first will seek FDA go-ahead for use in quality control testing, which would satisfy the forthcoming American Association of Blood Banks standard, effective in March. The nucleic acid test is being designed to provide same-day results - valuable given the limited five-day shelf life of platelets, and is superior to competitors Pall and Biomerieux, whose tests require 48 hours, according to Chiron. The firm believes it is well positioned for immediate success in the estimated $100 mil. market due to the ubiquity of the Procleix platform in blood banks. However, the platelet test will require a separate platform, yet to be determined...
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