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DiaSorin Receives CE Mark for Varicella-Zoster Virus Assay

NEW YORK  (GenomeWeb) – DiaSorin announced today that it has received CE marking for its Simplexa VZV Direct Assay for the direct detection of varicella-zoster virus (VZV) — which causes chickenpox and shingles — from a patient's cerebrospinal fluid.

The molecular assay, designed for use with DiaSorin's Liaison MDx instrument, will run alongside the firm's US Food and Drug Administration-cleared Molecular Simplexa HSV 1 & 2 Direct assay. Together, the assays can  produce comprehensive results for patients with suspected infections in the central nervous system, the company said.

"Our VZV assay delivers answers in about an hour, features an easy workflow with minimal hands-on time, and does not require upfront extraction," DiaSorin Chief Scientific Officer Michelle Tabb said in a statement. "The assay is fast, giving the physician the targeted answers [that] he/she is looking for."

Partnering with Qiagen, Italy-based Diasorin previously received a CE mark last month for a jointly developed automated workflow for latent tuberculosis. DiaSorin also received US FDA approval in August for its Molecular Simplex Bordetella Direct real-time PCR assay.