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What’s new with DiaSorin Molecular.

Available here is a selection of our latest press releases and news stories.
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Published on 17 Sep 2020

DiaSorin Molecular’s Simplexa™ COVID-19 Direct Molecular Test CE Marked for Saliva Specimens

Cypress, Calif. (September 17, 2020) – DiaSorin Molecular LLC announced today that it has attained CE Marking for the addition of saliva specimens for use with the Simplexa COVID-19 Direct assay. This new specimen claim enables additional flexibility for laboratories to increase capacity, overcome ongoing bottlenecks, and better manage worldwide swab and transport media shortages to detect SARS-CoV-2 RNA in patients suspected of COVID-19 infection.


DiaSorin Molecular
Published on 8 Sep 2020

DiaSorin Molecular receives FDA clearance for the Simplexa™ Flu A/B & RSV Direct Gen II Assay. A partner to run with the Simplexa™ COVID-19 Direct assay.

Cypress, Calif. (September 8, 2020) – DiaSorin Molecular LLC announced today that it has received FDA Clearance for its Simplexa™ Flu A/B & RSV Direct Gen II kit. The Simplexa Flu A/B & RSV Direct Gen II assay provides flexibility in workflow management for the upcoming flu season as the assay can be run alone or alongside the Simplexa COVID-19 Direct kit, allowing for differential diagnosis of SARS-CoV-2, influenza A (Flu A), influenza B (Flu B), and respiratory syncytial virus (RSV).


DiaSorin Molecular
Published on 7 Jul 2020

DiaSorin Molecular CE marks their new Simplexa™ Flu A/B & RSV Direct Gen II Assay to run with the Simplexa™ COVID-19 Direct assay

Cypress, Calif. (July 7, 2020) – DiaSorin Molecular LLC announced today that it has CE marked its Simplexa™ Flu A/B & RSV Direct Gen II kit. DiaSorin Molecular’s latest generation Simplexa Flu A/B & RSV Direct Gen II kit delivers continued comprehensive strain coverage and accurate detection in an efficient and trusted sample-to-answer format that does not require extraction. Collectively, over 100 Flu A, Flu B and RSV strains have been validated, including the 2020/2021 influenza vaccine strains. The Simplexa Flu A/B & RSV Direct Gen II assay is designed for use with the LIAISON® MDX instrument.


DiaSorin Molecular
Published on 15 Jun 2020

DiaSorin Molecular’s Simplexa™ Congenital CMV Direct Assay Attains CE Mark

Cypress, Calif. (June 15, 2020) – DiaSorin Molecular LLC announced today that it has received CE marking for its Simplexa™ Congenital CMV Direct kit. The new molecular diagnostic test enables direct detection of cytomegalovirus DNA in both saliva swab and urine specimens from babies up to 21 days old. It is the first CE marked assay that can be run directly from both saliva swab and urine. The assay is designed for use with the LIAISON® MDX instrument.


DiaSorin Molecular
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.


DiaSorin Molecular
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
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
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
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
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