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FDA clears Simplexa VZV Swab Direct

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February 2020—DiaSorin Molecular has received FDA clearance for its Simplexa VZV Swab Direct assay. The CLIA moderate-complexity assay is designed for use on the Liaison MDX instrument to detect varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens. The assay complements the company’s Simplexa VZV Direct kit, which is for use with cerebrospinal fluid samples.

The assay received the CE mark in September.

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