FDA Clears Focus Diagnostics HSV MDx | GenomeWeb

NEW YORK (GenomeWeb News) – Quest Diagnostics today announced that its Focus Diagnostics business has received expedited 510(k) clearance from the US Food and Drug Administration and CLIA moderate complexity categorization for its Simplexa HSV 1&2 Direct molecular test on the 3M Integrated Cycler.

Quest said the test is the first molecular assay cleared by FDA for the qualitative detection and characterization of herpes simplex virus 1 and HSV 2 in cerebrospinal fluid from patients who are suspected of having HSV central nervous system infection.

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