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What’s new with DiaSorin Molecular.

Available here is a selection of our latest news about DiaSorin Molecular.
Filtered by year 2019
Published on 17 Dec 2019

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

Cypress, Calif. (December 17, 2019) – DiaSorin Molecular LLC announced today that it has received FDA clearance for its Simplexa™ VZV Swab Direct assay. The CLIA moderate-complexity assay is designed for use on the LIAISON® MDX instrument to quickly and accurately detect varicella-zoster virus (VZV) DNA from cutaneous and mucocutaneous swab specimens. The company also attained CE Marketing for the assay in September. This assay complements the company’s Simplexa VZV Direct kit, which is for use with CSF samples.

DiaSorin Molecular
Press Release
Published on 12 Nov 2019

DiaSorin Molecular Introduces Primer Pair for Candida auris

Cypress, Calif. (November 12, 2019) – DiaSorin Molecular LLC announced today that it has released a new primer pair for use in laboratory-developed molecular tests that targets the yeast Candida auris. The company is a leader in the development and manufacture of primer pairs with a menu of more than 65 products for bacterial, viral and fungal targets, as well as human genetic mutations. The primer pairs are classified as Analyte Specific Reagents (ASRs), which can be used by high-complexity laboratories to develop their own laboratory developed tests (LDTs).

DiaSorin Molecular
Press release
Published on 25 Sep 2019

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
Press release
Published on 30 May 2019

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 & 2 Direct assay

DiaSorin Molecular
Press release
Published on 16 May 2019

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
Press release
Published on 8 Jan 2019

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
Press release