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Supplemental HIV Testing Market Woes Force FDA To Consider Other Options

This article was originally published in The Gray Sheet

Executive Summary

The financial instability of Calypte Biomedical over the past several months has increased FDA's interest in licensing alternative approaches for confirmatory HIV testing for blood banks, including nucleic acid testing

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HIV test shortage

Calypte Biomedical's April announcement of possible bankruptcy triggers CDC's May 10 warning of potential U.S. shortage of supplemental tests kits for confirmatory testing of HIV antibodies in specimens derived from patients or blood donors. Distributor bioMérieux has notified customers of a halt in Cambridge Biotech HIV-1 Western blot kit shipments. CDC and FDA have contacted other HIV test-makers, including BioRad Laboratories and OraSure, about ramping up kit production. Labs experiencing shortage should contact CDC at 404-639-4581...

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