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EraGen receives FDA clearance for Herpes test

Posted May 20 2010 7:54pm
EraGen Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for EraGen’s MultiCode®-RTx HSV 1&2 Kit. “EraGen’s HSV 1&2 Kit is the first FDA-cleared, molecular test for the herpes simplex virus. It has considerable advantages over the traditional testing methodologies used today for the detection and typing of the virus in symptomatic women,” said Irene Hrusovsky, M.D., president and chief executive of EraGen.
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