DiaSorin Gains FDA Clearance for VZV Swab Assay

December 19, 2019

The FDA granted clearance for DiaSorin’s Simplexa VZV Swab Direct assay for detection of ┬ávaricella-zoster virus from cutaneous and mucocutaneous swab samples.

The assay is designed for use on the company’s Liaison MDX system, a thermocycler that can accommodate both sample-to-answer testing and higher volume testing.

The company received the FDA’s clearance for the Simplexa VZV Direct assay in June, which uses cerebrospinal fluid samples.

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