FDA Ruling Boosts Trinity Biotech
Trinity Biotech (TRIB ) shares soared after regulators issued a waiver for the company's HIV test, broadening its legal use.
Shares rose 37 cents, or 12.2%, to $3.39 in heavy trading. More than 1.5 million shares changed hands, six times the normal daily volume.
Trinity's Uni-Gold Recombigen HIV test, which gives results within 10 minutes, was approved by the Food and Drug Administration last December.
The product has been waived for use in detecting HIV-1 antibodies in venous whole blood samples. The company said the waiver means it can now be used by almost 200,000 test sites in the U.S., including physician's offices and clinics, in addition to its previously approved applicability in the hospital environment.The test detects antibodies to HIV in human serum, plasma and whole blood.
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