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Medical Devices / Submissions and Approvals

FDA Clears DiaSorin Molecular’s VZV Assay

June 4, 2019
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DiaSorin Molecular has nabbed the FDA’s clearance for its Simplexa VZV Direct assay, a molecular diagnostic test used to detect the varicella-zoster virus (VZV).

The diagnostic—which is meant to be used alongside the company’s HSV 1 and 2 direct assay—is used with samples of cerebrospinal fluid to detect virus DNA, making it effective in the diagnosis of meningitis and encephalitis.

VZV causes varicella (chickenpox), a highly transmissible disease most commonly experienced in early childhood that can cause acute meningitis.

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