FDA approves Illumigene HSV 1&2 diagnostics for herpes simplex- Meridian Bioscience

Meridian Bioscience has received FDA clearance for two new molecular assays for the detection of herpes simplex virus Type 1 (HSV-1) and Type 2 (HSV-2), to be run on its Illumigene molecular platform. The Illumigene HSV 1&2 assays, launched in May this year in Europe, are now available in the US – they are the eighth and ninth assays added to the illumigene molecular menu now that includes C. difficile, Group A Streptococcus, Group B Streptococcus, Mycoplasma, Pertussis, Chlamydia and Gonorrhea.

Illumigene HSV 1&2 assays utilize loop-mediated isothermal DNA amplification (LAMP) technology for the qualitative detection and differentiation of HSV-1 and HSV-2 in cutaneous and mucocutaneous specimens. The test procedure is simple, sensitive and provides results in less than one hour.