Focus Technologies West Nile testing
This article was originally published in The Gray Sheet
Executive Summary
Herndon, Va.-based firm files 510(k) with FDA for West Nile virus IgM and IgG ELISA diagnostic kits June 25 upon completion of clinical trials. Focus began shipping WNV flavivirus reagents to commercial and public labs in April (1"The Gray Sheet" May 5, 2003, In Brief)...
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Focus Technologies begins shipments of Flavivirus (WNV) antibody detection reagents to public and commercial labs April 29. Based on protein antigen technology licensed from CDC, the analyte-specific reagent configurations will now be evaluated by major U.S. labs. Ongoing clinical trials at Mayo Clinic and the New York Department of Health will support a 510(k) submission to FDA this summer, and also will determine if the test is sufficiently sensitive to yield conclusive results without plaque reduction neutralization testing (RPNT), currently required for confirmation (1"The Gray Sheet" March 17, 2003, p. 8). In June, Focus will begin offering confirmatory PRNT in its lab as an alternative to public health testing options...
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