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OraSure HIV test nears market entry

This article was originally published in The Gray Sheet

Executive Summary

Firm targets "mid-summer" launch for its combined OraQuick HIV-1/2 rapid oral fluid test. Prior to launch, OraSure must obtain licensing rights for the test's HIV-2 marker from Bio-Rad and a Clinical Laboratory Improvement Amendments (CLIA) waiver for the diagnostic's oral fluid component. Further, the firm needs FDA clearance for the test's HIV-2 portion; the HIV-1 part received clearance March 26. OraSure plans to submit HIV-2 data and completed clinical tests for the CLIA waiver by June (1"The Gray Sheet" March 29, 2004, p. 3)...

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