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FDA Clears EraGen Kit for HSV 1&2 Detection and Typing on bioMérieux Platform

NEW YORK (GenomeWeb News) – EraGen Biosciences today announced the US Food and Drug Administration has cleared its MultiCode-RTx HSV 1&2 kit for use on bioMérieux's NucliSens easyMag extraction system.

As a result, laboratories can now use either Roche's MagNa Pure system or the easyMag extraction system with the kit.

The MultiCode-RTx HSV 1&2 test is PCR-based and provides qualitative testing and typing of HSV 1 and 2 in about four hours, EraGen said, adding that the recent clearance of a second extraction system makes the test available to labs without the MagNa Pure system.

The 510(k) clearance is for the detection and typing of herpes simplex virus 1 and 2 in vaginal lesion swab specimens from symptomatic female patients 18 years of age and older as an aid for diagnosing genital herpes infection. The device is not cleared by FDA for use in cerebrospinal fluid or lesions other than vaginal, EraGen, a Luminex company, said.