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Viral Testing Systems

This article was originally published in The Gray Sheet

Executive Summary

Receives FDA investigational new drug approval to begin U.S. clinical trials of its Fluorognost HIV-2 immunofluorescence assay. The IND was filed approximately three months ago ("The Gray Sheet" Jan. 11, In Brief). The firm hopes to submit data from the trials to FDA's Center for Biologics Evaluation and Research by October. The test is based on the same technology as VTS' Fluorognost HIV-1 assay, which was approved last year. VTS licenses rights to both tests from Waldheim Pharmazeutika, an Austrian firm.
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