Diasorin S.p.a.MIL: DIA

DiaSorin S p A launches LIAISON® TSH-R Ab, an immunodiagnostic assay to improve Graves’ Disease diagnosis, in all countries accepting CE mark

· Issued by Diasorin S.p.a.
Diasorin launches LIAISON®TSH-R Ab, an immunodiagnostic assay to improve Graves' Disease diagnosis, in all countries accepting CE mark

THE LIAISON®TSH-R AB:

  • supports clinicians in diagnosing Graves' Disease, the most common autoimmune thyroid disorder, distinguishing it from other forms of hyperthyroidism, and monitoring patient therapy;

  • IS A FULLY AUTOMATED IMMUNODIAGNOSTIC ASSAY THAT UTILIZES AN INNOVATIVE ASSAY PRINCIPLE FOR ENHANCED PERFORMANCE AND RELIABILITY;

  • is available on the LIAISON®CLIA family analyzers and in all countries recognizing the CE Mark, in compliance with IVD Regulation 2017/746 (IVDR).

Saluggia, Italy - September 19, 2025 - Diasorin (FTSE MIB: DIA) today announces the launch of the new LIAISON®TSH-R Ab assay, available in all countries recognizing the CE Mark. This assay is specifically developed to aid in the diagnosis and monitoring of patients with suspected Graves' Disease, an autoimmune disorder characterized by autoantibodies, TSH-Receptor antibodies (TSH-R Ab), that can stimulate thyroid receptors, leading to increased production and release of hormones by the gland.

Graves' Disease is the most common autoimmune thyroid disorder, accounting for approximately 60%-80% of all hyperthyroidism cases. It affects 0,5% to 3% of the general population. If left untreated, the disease can cause a range of complications, including cardiovascular, eye and skin problems, osteoporosis, and in severe cases, a life-threatening condition called thyroid or thyrotoxic storm.

Autoimmune thyroid diseases are frequently underdiagnosed. The availability of specific immunoassays to detect autoantibodies such as TSH-R Ab, alongside other autoimmune thyroid markers (e.g., Anti-TPO, Anti-TG) and thyroid function tests (e.g., TSH, FT3, FT4), enables clinicians to make faster and more accurate diagnoses, in line with international clinical guidelines.

The new LIAISON®TSH-R Ab assay enhances patient management by enabling effective monitoring of therapy in individuals with Graves' Disease. It features a novel, double-bridge technology, sandwich assay, which significantly improves performances and reliability.

"With the launch of the LIAISON®TSH-R Ab assay,

e are reinforcing our commitment to providing clinicians
ith advanced tools for accurate and timely diagnosis," said Chen Even, Chief Commercial Officer at Diasorin. "This assay not only elevates diagnostic accuracy for Graves' Disease but also facilitates comprehensive patient management, reflecting our commitment to advancing patient outcomes through innovative solutions."

This new assay complements Diasorin's comprehensive LIAISON®Thyroid and Autoimmune Thyroid panels, offering laboratories the convenience of a complete thyroid testing solution on a single platform.

With the introduction of the LIAISON®TSH-R Ab assay, Diasorin continues to expand its specialized

offering in autoimmune diagnostics. This new assay provides laboratories with a valuable tool to support the diagnosis and monitoring of Graves' Disease, reinforcing the Group's commitment to innovation and the continuous improvement of the clinical utility of its diagnostic solutions.

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 31 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 https://www.diasorin.com

For additional information, please contact: Investor Relations Riccardo Fava Eugenia Ragazzo

Corporate VP Communication, ESG & Investor Relations Corporate Investor Relations & ESG Senior Analyst

riccardo.fava@diasorin.com eugenia.ragazzo@diasorin.com

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