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Trinity Biotech Uni-Gold Recombigen

This article was originally published in The Gray Sheet

Executive Summary

Rapid HIV antibody blood test gains CLIA waiver for use with finger stick whole blood samples, an indication approved by FDA earlier this year (1"The Gray Sheet" Oct. 4, 2004, In Brief). The waiver gives Trinity access to the public health market, which the firm estimates to be about three times the size of the hospital lab segment, where the test currently competes. OraSure's OraQuick Advance oral fluid test is the only other CLIA-waived, FDA-approved rapid HIV test for the public health market (2"The Gray Sheet" Oct. 25, 2004, In Brief)...

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