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EraGen Gets FDA OK for Herpes MDx Test

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.

"With the clearance of EraGen's HSV 1&2 Kit, clinical laboratories can now provide PCR-based, qualitative detection of HSV types 1 or 2 as indicated in the package insert in approximately four hours utilizing a common nucleic acid extraction system and real-time PCR instrument," Maria Foster, EraGen's VP of commercial operations, said in a statement.

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