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Medical Devices / Submissions and Approvals

DiaSorin Molecular’s Herpes Assay Grabs CE Mark

May 20, 2019

DiaSorin Molecular earned the CE Mark for its Simplexa HSV 1/2 and VZV Universal Direct MDx assay, a diagnostic for the herpes simplex and varicella-zoster viruses.

The assay is designed for use on the devicemaker’s Liaison MDx instrument. It can detect and differentiate between DNA associated with herpes 1 and 2 and the varicella-zoster virus, which causes shingles and chickenpox.

The real-time PCR assay does not require upfront extraction, produces results in about an hour and involves minimal hands-on interaction.

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