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Trinity Biotech Soars on FDA OK

Trinity Biotech (TRIB - Get Report) was Monday's premarket superstar, vaulting almost 60% after the Food and Drug Administration approved its 10-minute test for the virus that causes AIDS.

The shares were up $1.92, or 58.5%, to $5.20 after the FDA cleared for marketing Trinity's Uni-Gold Recombigen HIV test in the U.S. The company said its product looks for antibodies to HIV in human blood serum, plasma and whole blood, and needs only 10 minutes to produce a result.

Clearance of Uni-Gold followed clinical trials on more than 9,000 patient specimens where it had test sensitivity of 100% and a specificity of over 99.7%.

The company said the market for such tests in U.S. doctors' offices is "difficult to quantify" but said it will "clearly be significant."

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