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Meridian Bioscience HSV 1, HSV 2 Tests Get FDA Clearance

NEW YORK (GenomeWeb) – Meridian Biosciences said today that it has received clearance from the US Food and Drug Administration for the Illumigene HSV 1&2 assays.

The assays use loop-mediated isothermal amplification to detect the DNA of herpes simplex 1 and herpes simplex 2 virus from cutaneous and mucocutaneous patient samples in less than one hour, and had previously received CE mark in May.

The assays are the eighth and ninth tests on Illumigene's menu, which also includes tests for Clostridium difficile, Group A Streptococcus, Group B Streptococcus, mycoplasma, pertussis, chlamydia, and gonorrhea.

"Currently, approximately 60 percent of hospital laboratories are sending out their HSV-1 and HSV-2 test requests to an offsite testing facility, and a smaller percentage are performing viral culture in-house; both scenarios can take up to 1 week to report final results, creating an unnecessary delay in the delivery of patient care and the potential for transmission of the virus to new contacts," Mike Shaughnessy, executive vice president and president of Meridian Global Diagnostics, said in a statement.

"With more than 775,000 new cases of HSV-2 annually, and the majority of infections transmitted by people unaware of their infection, offering a test solution that allows providers to collect, test, and treat same in the day is paramount," Shaughnessy said.

The Illumigene tests are simple and sensitive, and the small-footprint platform obviates the need for expensive capital equipment, according to Meridian.