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Diasorin Releases an Updated Simplexa SARS-CoV-2 Variants Direct Molecular Assay (RUO) for the Detection of Mutations Associated with the Omicron Variant

Saluggia, January 13, 2022 - DiaSorin (FTSE MIB: DIA) announces today that it has released an updated version of the Simplexa™ SARS-CoV-2 Variants Direct assay (RUO) to enable the detection of mutations associated with the new Omicron variant (B.1.1.529).

The assay helps to streamline and expedite the pre-selection process of positive samples that would benefit from further sequencing, which maximizes the effectiveness of monitoring programs for the spread of concerning variants. 

The Simplexa™ SARS-CoV-2 Variants Direct is a Research Use Only (RUO) assay and is not for use in diagnostic procedures. The assay works directly on nasopharyngeal and nasal swab specimens that were identified as positive for SARS-CoV-2, and allows for the in vitro qualitative detection of the mutations E484A, E484K, E484Q, G496S, Q498R L452R, N501Y, and Y505H. These mutations are present in potential variants of clinical interest including Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Epsilon (B.1.427/B.1.429), Zeta (P.2), Eta (B.1.525), Iota (B.1.526/B.1.526.1), Kappa (B.1.617.1/ B.1.617.3), Mu (B.1.621), and Omicron (B1.1.529). The kit format consists of pre-aliquoted reagents that are ready for use while leveraging Direct Amplification Disc technology and the melting curve analysis capabilities of the LIAISON® MDX instrument.

The Center for Disease Control (CDC) expects that those infected with Omicron, regardless of vaccination status or presence of symptoms will likely spread the infection more easily than the original SARS-CoV2 virus. While more data are collected to determine if the Omicron variant will cause more severe illness or death than infection with other variants, surveillance is ongoing to track the spread around the globe. The availability of affordable molecular solutions that can be implemented easily and provide quick results will facilitate and increase the ability to monitor the spread of variants by streamlining laboratory workflows. 

“As soon as the new Omicron variant was described, our R&D team quickly worked to implement the ability to detect the mutations characteristic for this variant of concern,” said Michelle Tabb, Chief Scientific Officer of DiaSorin Molecular. “This further confirms DiaSorin’s ability to promptly react to new and evolving needs of COVID-19 diagnostics.” 

For additional information, please contact: 

Riccardo Fava
Corporate Vice President Communication & Investor Relations
39 0161 487988
e-mail: [email protected]

Emanuela Salvini
Investor Relator
39 0161 487567
e-mail: [email protected]

About DiaSorin

Headquartered in Italy and listed at the Italian Stock Exchange in the FTSE MIB Index, DiaSorin is a global leader in the In Vitro Diagnostic (IVD) field and is active since 2021 in the Life Science business. For over 50 years, the Company has been developing, producing and marketing reagent kits used by diagnostic laboratories worldwide. 

The Group operates in 5 continents through 45 companies, 4 branches, 10 manufacturing facilities and 9 research and development centers. The extensive diagnostic testing and Life Science offer, made available through continuous investments in research, positions DiaSorin as the player with the broadest range of specialty tests available within the diagnostic market, and identifies the Group as the “Diagnostic Specialist”. 

More info at www.diasoringroup.com