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DiaSorin Molecular’s Simplexa™ VZV Swab Direct Molecular Assay Gets CE Mark

Cypress, Calif. (September 25, 2019) – DiaSorin Molecular LLC announced today 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

DiaSorin Molecular Receives FDA Clearance for Simplexa™ VZV Direct Molecular Assay

Cypress, Calif. (May 30, 2019) – DiaSorin Molecular LLC announced today that it has received FDA clearance for its new Simplexa™ VZV Direct assay for use with cerebrospinal fluid (CSF) samples. The new molecular diagnostic test enables the detection of varicella-zoster virus (VZV) DNA from CSF and serves as an effective tool to aid in the diagnosis of meningitis and encephalitis. Requiring only 50µL of patient CSF per test, the assay was developed for use on DiaSorin Molecular’s LIAISON® MDX instrument and complements DiaSorin Molecular’s Simplexa HSV 1 &

DiaSorin Molecular Attains CE Mark for Simplexa HSV 1/2 & VZV Universal Direct Molecular Assay

Cypress, Calif. (May 16, 2019) – DiaSorin Molecular LLC announced today that it has received CE marking for its new SimplexaTM HSV 1/2 & VZV Universal Direct assay. The new molecular diagnostic test enables the direct detection and differentiation of herpes simplex virus (HSV)-1, HSV-2 and varicella-zoster virus (VZV) DNA from cutaneous and mucocutaneous swab specimens. The assay was designed for use on the LIAISON® MDX instrument and generates comprehensive and actionable insight for patients with lesions.

DiaSorin Molecular Receives FDA Clearance for Bordetella Test

Cypress, Calif., January 8, 2019 – DiaSorin Molecular LLC announced today that it has received FDA clearance for its new Simplexa® Bordetella Direct test. This CLIA moderate-complexity assay is designed for use on the LIAISON® MDX to quickly provide qualitative detection and differentiation of both Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs (NPS). The assay is performed directly from NPS samples without extraction and provides results in about an hour.

DiaSorin Molecular Introduces Three New Primer Pairs for Atypical Pneumonia

Cypress, Calif. (December 20, 2018) – DiaSorin Molecular LLC announces the availability of three new primer pairs, or Analyte Specific Reagents (ASRs), which can be used in laboratory-developed tests (LDTs). The specific targets are Legionella species, Chlamydophila pneumoniae and Mycoplasma pneumoniae, all of which may infect the lungs.