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Viral Testing Sciences

This article was originally published in The Gray Sheet

Executive Summary

Submits investigational new drug application to FDA for its Fluorognost HIV-2 immunofluorescence confirmatory test. Currently, there is no FDA-approved confirmation test for detecting antibodies to HIV-2. The Fluorognost HIV-2 test is based on the same technology utilized in the Fluorognost HIV-1 test, which was approved for confirmatory and screening use last year ("The Gray Sheet" March 2, p. 9). Pending FDA approval of the IND, clinical studies of the test will be conducted by the American Red Cross in Washington, D.C.; the South Florida Blood Center in Miami; Serologicals, Inc. in Georgia; and the Minneapolis state laboratory. VST was formed through the merging of Thermascan and TeleConcepts ("The Gray Sheet" Nov. 23, p. 18)....
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