FDA Clears DiaSorin Molecular’s VZV Assay
June 3, 2019
DiaSorin Molecular has nabbed the FDA’s clearance for its Simplexa VZV Direct assay, a molecular diagnostic test used to detect the varicella-zoster virus (VZV).
The diagnostic—which is meant to be used alongside the company’s HSV 1 and 2 direct assay—is used with samples of cerebrospinal fluid to detect virus DNA, making it effective in the diagnosis of meningitis and encephalitis.
VZV causes varicella (chickenpox), a highly transmissible disease most commonly experienced in early childhood that can cause acute meningitis.