New & Noteworthy

September 2018

Direct Assay Receives Clearance

Diasorin

DiaSorin Molecular has received FDA clearance extending the sample type claims of its Simplexa HSV 1 & 2 Direct assay. The clearance expands the type of samples that can be tested, from genital swabs to all cutaneous and mucocutaneous swab samples. The real-time PCR assay, for use on DiaSorin Molecular’s LIAISON MDX instrument, is intended for the in vitro qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid and swab samples. The test does not require a DNA extraction step and processes up to eight samples per run in about one hour.

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