The FDA has given 510(k) clearance to Hologic for its Aptima Herpes Simplex Virus 1 & 2 molecular assay as part of its fully automated Panther system. The nucleic acid amplification test, intended to be used with swab specimens from anogenital skin lesions, helps in the diagnosis of HSV-1 or HSV-2 infections and can also be used to distinguish between the two.
FDA clears Hologic's HSV assay on Panther system
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