EraGen Gets FDA OK for Herpes MDx Test | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – EraGen Biosciences has received US Food and Drug Administration clearance for its molecular test for herpes simplex virus, the firm said today.

The Madison, Wis.-based company said that its MultiCode-RTx HSV 1&2 Kit received 510(k) market clearance, which it said is the first molecular test for herpes simplex virus to be cleared by FDA. The test uses the firm's novel synthetic DNA base pair isoC:isoG, and detects and types HSV 1 and 2 DNA in vaginal lesions.

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