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FDA Clears DiaSorin HSV Assay for Extended Swab Sample Claims

The article has been updated to correct the types of new samples covered by the expanded FDA clearance. 

NEW YORK (GenomeWeb) – DiaSorin Molecular said today it has received a US Food and Drug Administration clearance that extends the sample type claims for its Simplexa HSV 1 & 2 Direct assay, expanding the type of samples that can be tested to all cutaneous and mucocutaneous swab samples.  

The test was cleared by the FDA in 2014 for use with cerebrospinal fluid samples. It also had been cleared for use with genetic swabs. DiaSorin acquired the test as part of its acquisition of Focus Diagnostics from Quest Diagnostics in 2016. DiaSorin received CE marking for the extended sample claims late last year.

The real-time PCR assay for use on its Liaison MDX instrument is intended for the in vitro qualitative detection and differentiation of HSV-1 and HSV-2 DNA without the need for a DNA extraction step. Up to eight samples per run can be processed in about one hour, DiaSorin said.

"We are continually growing our test menu and expanding what the individual tests can do," Michelle Tabb, vice president of research and development for DiaSorin Molecular, said in a statement. "This makes our molecular platform very attractive to clinical laboratories."