DiaSorin Molecular’s Simplexa VZV Swab Direct MDx assay achieves CE Mark

Sept. 26, 2019

DiaSorin Molecular LLC announced that it has received CE marking for its Simplexa VZV Swab Direct assay. The new molecular diagnostic test enables the direct detection of varicella-zoster virus (VZV) DNA from both cutaneous and mucocutaneous swab specimens. The assay is used with the LIAISON MDX instrument and complements the company’s Simplexa HSV 1 & 2 Direct kit. DiaSorin Molecular has also submitted the Simplexa VZV Swab assay to the FDA for 510(k) clearance.

Varicella-zoster virus infection causes two clinically distinct forms of disease, depending on whether an individual is experiencing a primary (chickenpox) or secondary (shingles) infection. Chickenpox is a highly contagious disease that is usually contracted in early childhood. It can cause health complications especially in older individuals. After initial infection, VZV becomes latent in sensory nerve ganglia and can reactivate later in life to cause shingles (herpes zoster). This is a painful condition that can result in complications such as post-herpetic neuralgia and central nervous system infections. Although several vaccines have been available since the 1990s, it is estimated that greater than 90 percent of the population will acquire the disease by the age of 15. The clinical presentation of zoster can often be confused with the dermal manifestation of HSV, which makes it important to detect VZV rapidly for proper patient treatment and management.

“We are committed to expanding our menu of high-quality assays that can be used with our LIAISON MDX platform,” commented Michelle Tabb, chief scientific officer at DiaSorin Molecular. “Customers are looking to consolidate the testing platforms in their labs. The workflow efficiencies we deliver and our rapidly growing test menu make our platform increasingly attractive and in demand.”

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