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Chembio Clears Path For HIV Tests With Patent, Marketing Agreement

This article was originally published in The Gray Sheet

Executive Summary

Chembio settled its legal disputes and found a marketing partner for its recently approved rapid HIV tests in a three-party agreement announced Oct. 5

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Clearview Complete HIV 1/2 is the latest rapid HIV test to gain a waiver for use in physicians' offices and clinics under the Clinical Laboratory Improvements Amendments, announced Nov. 2. The test, which uses "barrel" technology developed by StatSure Diagnostic Systems to detect antibodies in blood, serum and plasma, is manufactured by Chembio and marketed and distributed worldwide by Inverness Medical Innovations. Other CLIA-waived rapid HIV tests include OraSure's OraQuick Advance, Trinity's Uni-Gold Recombigen and Chembio's HIV 1/2 Stat-Pak (1"The Gray Sheet" Oct. 9, 2006, p. 16).

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