Simplexa VZV Direct gets FDA clearance

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June 13, 2019–DiaSorin Molecular received FDA clearance for its Simplexa VZV Direct assay for use with cerebrospinal fluid samples. The molecular diagnostic test enables the detection of varicella zoster virus DNA and aids in the diagnosis of meningitis and encephalitis.

“HSV 1, HSV 2, and VZV CSF PCR are part of the diagnostic algorithm for encephalitis in adults,” Michelle Tabb, chief scientific officer, DiaSorin Molecular, said in a press release. “Our new VZV Direct assay, together with our HSV 1 & 2 Direct assay, provides physicians the answers they require in a timely manner for patient management.”