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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Trinity Biotech Uni-Gold Recombigen
Rapid HIV antibody test gains FDA go-ahead for use with fingerstick whole blood, boosting its marketing potential "significantly" beyond approvals received in 2003 covering serum, plasma and whole blood, Trinity says. The firm has applied to expand its venous whole-blood CLIA waiver to include the new indication...
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