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In Brief: OraSure HIV-1 test

This article was originally published in The Tan Sheet

Executive Summary

OraSure HIV-1 test: SmithKline Beecham's rollout of the professional-use diagnostic test will commence in 2-3 months following FDA's June 3 approval of the OraSure HIV-1 Western Blot Kit Premarket Approval Application. The kit will be marketed to physicians' offices, private testing sites, public health departments, community-based health services and AIDS service organizations. The test kit includes a swab for collecting a cheek/gum tissue sample, which is sent to a lab for HIV-1 antibody screening and, if needed, Western Blot confirmatory testing. SmithKline and product manufacturer Epitope later plan to seek clearance for OTC marketing of the OraSure test...
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