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SmithKline Consumer Healthcare to market Epitope's OraSure HIV sample collection kit.

This article was originally published in The Gray Sheet

Executive Summary

SMITHKLINE CONSUMER HEALTHCARE TO MARKET EPITOPE'S ORASURE oral specimen collection kit for HIV-1 antibody testing under an agreement in principle announced Feb. 21. The agreement provides the SmithKline OTC drug unit with rights to sell the device in the U.S. and most worldwide markets. The kit, along with an Organon Teknika HIV-1 test for laboratory testing of the collected samples, was approved by FDA on Dec. 23, 1994 "for purchase and distribution only through physicians" ("The Gray Sheet" Jan. 2, p. 1).
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