www.fdanews.com/articles/191340-diasorin-moleculars-herpes-assay-grabs-ce-mark
DiaSorin Molecular’s Herpes Assay Grabs CE Mark
May 17, 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.