DiaSorin Molecular Attains CE Mark for Simplexa™ VZV Direct Molecular Assay

DiaSorin Molecular has announced that it has received CE marking for its new Simplexa™ VZV Direct assay. The new molecular diagnostic test enables the direct detection of varicella-zoster virus (VZV) DNA from cerebrospinal fluid (CSF). The assay was designed for use on the LIAISON^® MDX instrument and will be able to run alongside DiaSorin Molecular’s Simplexa HSV 1 & 2 Direct assay, generating comprehensive and actionable insight for patients with suspected infections of the central nervous system (CNS).

VZV causes varicella (chickenpox), a highly communicable disease that is usually contracted in early childhood. Chickenpox is typically a mild disease, but can cause complications and, in rare instances, death. After initial infection, VZV becomes latent in sensory nerve ganglia. Reactivation occurs with increased age or immunosuppression and causes herpes zoster (shingles), a painful condition associated with complications including post-herpetic neuralgia and CNS infections. Although several vaccines have been available since the 1990s, recommendations and implementation vary by country. It is estimated that greater than 90 percent of the population will acquire the disease by the age of 15 and each of these persons is at risk for developing encephalitis caused by VZV.

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“Our VZV assay delivers answers in about an hour, features an easy workflow with minimal hands-on time and does not require upfront extraction,” commented Michelle Tabb, chief scientific officer at DiaSorin Molecular. “The assay is fast, giving the physician the targeted answers he/she is looking for in a timely manner.”