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DiaSorin Molecular Gets CE Mark for Herpes Virus Assay

NEW YORK (GenomeWeb) – Cypress, California-based DiaSorin Molecular said today that it has received CE marking for its Simplexa HSV 1/2 & VZV Universal Direct MDx assay designed for use on the firm's Liaison MDx instrument.

The assay uses cutaneous and mucocutaneous swab specimens for the direct detection and differentiation of DNA associated with herpes simplex virus type 1 (HSV-1), HSV-2, and varicella-zoster virus (VZV).

Testing for VZV with HSV-1 and HSV-2 may enable clinicians to provide improved therapeutic decisions and advice, DiaSorin said.

"Our HSV and VZV assay delivers answers for these related herpes viruses in a single reaction in about an hour, features an easy workflow with minimal hands-on time, and does not require upfront extraction," Michelle Tabb, chief scientific officer at DiaSorin Molecular, said in a statement.

HSV-1, HSV-2, and VZV are human herpes viruses that can cause genital vesicular lesions. A majority of genital lesions are caused by HSV-1 or HSV-2 or both, but nearly 3 percent of genital lesions are associated with VZV.

VZV causes chickenpox, often a relatively mild disease that can nonetheless cause complications and is characterized by lesions on the face, trunk, and extremities. The virus can also cause herpes zoster, or shingles, a painful condition associated with complications that include post-herpetic neuralgia and CNS infections. After an initial infection, VZV becomes latent in sensory nerve ganglia but reactivation occurs with increased age or immunosuppression and materializes as shingles, DiaSorin said.

DiaSorin's Simplexa line of MDx tests are real-time PCR assays designed for multi-analyte detection.

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