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FDA Clears DiaSorin Molecular Meningitis, Encephalitis Assay

NEW YORK (GenomeWeb) – DiaSorin Molecular said today that the US Food and Drug Administration has cleared the company's Simplexa VZV Direct assay for detecting varicella-zoster virus.

The assay is for use with cerebrospinal fluid samples and can help in diagnosing meningitis and encephalitis. It requires 50 microliters of CSF per test and can be used with DiaSorin Molecular's Liaison MDx instrument. It also complements the Cypress, California-based firm's Simplexa HSV 1 and 2 Direct assay, the company said.

"HSV 1, HSV 2, and VZV CSF PCR are part of the diagnostics algorithm for encephalitis in adults," DiaSorin Molecular CSO Michelle Tabb said in a statement. "Our new VZV Direct assay, together with our HSV 1 & 2 assay, provides physicians the answers they require in a timely manner for patient management."

Earlier in the month, the firm announced it received CE marking for its Simplexa HSV 1/2 & VZV Universal Direct MDx assay designed for use on the firm's Liaison MDx platform.

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