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Available here is a selection of our latest news about DiaSorin Molecular.
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Published on 1 Apr 2020

News Story: DiaSorin Molecular Has Attained CE Marking for COVID-19 Test

Cypress, Calif. (April 1, 2020) – DiaSorin Molecular LLC announced today that it has attained CE Marking for their Simplexa™ COVID-19 Direct kit, a sample-to-answer test for the detection of SARS-CoV-2, the virus that causes COVID-19, using nasopharyngeal swab specimens. The company also announced it had received Emergency Use Authorization (EUA) from the FDA on March 20, 2020.

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Published on 20 Mar 2020

DiaSorin Molecular COVID-19 Test Has Received FDA Emergency Use Authorization

Cypress, Calif. (March 20, 2020) – DiaSorin Molecular LLC announced today that it has received Emergency Use Authorization (EUA) from the FDA for their Simplexa™ COVID-19 Direct kit. The kit provides a sample-to-answer test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, directly from nasopharyngeal swab specimens.

DiaSorin Molecular
Press release
Published on 13 Mar 2020

DiaSorin Molecular to Receive BARDA Funding to Develop a Rapid COVID-19 Test

Cypress, Calif. (March 13, 2020) – DiaSorin Molecular LLC announced today that it will receive federal funds from the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, in order to develop a molecular test for qualitative identification of the novel coronavirus SARS-CoV-2, which causes COVID-19 disease, in response to the evolving global health emergency.

DiaSorin Molecular
Press release
Published on 10 Mar 2020

DiaSorin has Completed the Studies to Support the Launch by the End of March 2020 of A Rapid Response Molecular Diagnostic Test for the Current Novel Coronavirus (COVID-19)

Saluggia – March 10, 2020 – DiaSorin (FTSE MIB: DIA) announced today that it has completed at the Spallanzani Hospital in Rome and at the Policlinico San Matteo in Pavia, the studies necessary to support the CE marking and FDA EUA submission of an innovative molecular test for the rapid identification of the novel coronavirus COVID-19.

DiaSorin Molecular
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Published on 2 Mar 2020

DiaSorin and TTP Sign Exclusive Licensing agreement for Molecular Diagnostic Point-of-Care Technology

March 2, 2020 – Saluggia, Italy and Cambridge, UK – DiaSorin (FTSE MIB: DIA) and TTP plc, a leading independent technology and product development company, today announced that they have signed an exclusive licensing and technology transfer agreement under which DiaSorin will gain access to TTP’s Puckdx™, a flexible and low-cost platform for the automation of sample-to-answer diagnostic assays.

DiaSorin Molecular
Press release
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