Proteome Sciences results in big news CJD + Stroke tests

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DUBLIN, Ireland, Dec. 29 /PRNewswire-FirstCall/ -- Trinity Biotech plc (Nasdaq: TRIB - News) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market its Uni-Gold Recombigen(TM) HIV test in the United States.

The product is approved for the detection of antibodies to HIV in human serum, plasma or whole blood and is the first and only device to be approved for use with all three sample types. Uni-Gold Recombigen(TM) HIV is simple to use, requiring only one step and produces a result within 10 minutes, whereas with conventional laboratory tests for HIV, results may not be available for hours or even days. Uni-Gold Recombigen(TM) HIV was approved by the FDA on the basis of clinical trial results on over 9,000 patient specimens where the product demonstrated a test sensitivity of 100% and a specificity of over 99.7%.

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Market opportunity by direct sales force $30M. Market cap rise $80M.