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Available here is a selection of our latest news about DiaSorin Molecular.
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Published on 7 Nov 2022

DIASORIN COMMERCIALIZES MOLECULAR REAGENT FOR MONKEYPOX VIRUS

Saluggia, Italy, November 7, 2022 – DiaSorin (FTSE MIB: DIA) announces its release of an Analyte Specific Reagent (ASR) primer pair that detects the B17R/B18R gene of the monkeypox virus, the orthopoxvirus responsible for the ongoing 2022 global public health emergency. The ASR can be used by high-complexity clinical laboratories to develop and validate assays to detect monkeypox virus DNA for diagnostic purposes as well as by non-clinical laboratories to develop and validate tests for research, forensic and other non-clinical purposes.

DiaSorin Molecular
Press Release
Published on 14 Sep 2022

The Simplexa™ COVID-19 Direct Test Receives U.S. FDA 510(K) Clearance

Cypress, Calif. (September 14, 2022) – DiaSorin Molecular announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Simplexa™ COVID-19 Direct kit. The kit provides a sample-to-answer test for the detection of SARS-CoV-2, the virus that causes COVID-19, directly from nasopharyngeal or nasal swab specimens. The Simplexa™ COVID-19 Direct kit is designed for use on the LIAISON® MDX system. This COVID-19 molecular assay can be utilized by hospital or commercial laboratories allowing for timely testing and highly accurate results.

DiaSorin Molecular
Press Release
Published on 20 Sep 2021

DiaSorin Molecular CE Marks their new Simplexa™ COVID-19 & Flu A/B Direct Assay for Detection and Differentiation of SARS-CoV-2 and Influenza in One Test.

Cypress, Calif. (September 20, 2021) – DiaSorin Molecular LLC announced today that it has CE marked its Simplexa™ COVID-19 & Flu A/B Direct kit. The multiplex test allows for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus from the same patient sample in one reaction well. The assay is designed for use on the LIAISON® MDX and is run directly from nasopharyngeal swabs (NPS) without the need for off board extraction. The kit will also be submitted to the FDA for 510(k) review.

DiaSorin Molecular
Press Release
Published on 14 Jul 2021

DiaSorin Announces Completion of the Acquisition of Luminex Corporation

Saluggia, July 14, 2021 – DiaSorin S.p.A. (“DiaSorin”; FTSE MIB: DIA) announces it has completed the acquisition of Luminex Corporation (“Luminex”; NASDAQ: LMNX) for a price of USD 37.00 per share that corresponds to a total equity value of approximately USD 1.8 billion.

DiaSorin Molecular
Press Release
Published on 21 May 2021

DiaSorin Molecular Releases an Assay for Rapid Identification of Mutations Associated with Circulating Variants of SARS-CoV-2, including the India B.1.617

Cypress, Calif. (May 21, 2021) – DiaSorin Molecular LLC announced today that it has released the Simplexa™ SARS-CoV-2 Variants Direct assay (RUO) to enable detection and discrimination of four SARS-CoV-2 mutations associated with circulating virus variants without requiring upfront RNA extraction. The assay helps to streamline and speed-up the pre-selection process of positive samples that need further sequencing, maximizing the effectiveness of monitoring programs for the spread of concerning variants.

DiaSorin Molecular
Press Release
Published on 13 Jan 2021

DiaSorin Molecular Receives Additional BARDA Funding in Support of Submitting the Simplexa™ COVID-19 Direct and the Simplexa™ COVID-19 & Flu A/B Direct kits for FDA 510(k) Clearance

Cypress, California (USA) – January 13, 2021 – DiaSorin Molecular LLC, a subsidiary of DiaSorin S.p.A. (FTSE MIB:DIA), announced today that it has received additional federal funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, for the validation and submission of the Simplexa COVID-19 Direct kit and the Simplexa COVID-19 & Flu A/B Direct kit for FDA 510(k) clearance. The company initially received BARDA funding in March 2020 to test, validate, and submit the Simplexa COVID-19 Direct kit for FDA Emergency Use Authorization (EUA).

DiaSorin Molecular
Press Release
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
Press Release
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
Press Release
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
Press release
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
Press release