Diasorin S.p.a.MIL: DIA

DiaSorin S p A Receives 510(K) Clearance for Fully Customizable LIAISON PLEX Gastrointestinal Flex Assay

· Issued by Diasorin S.p.a.
DIASORIN RECEIVES 510(K) CLEARANCE FOR FULLY CUSTOMIZABLE LIAISON PLEX GASTROINTESTINAL FLEX ASSAY

THE LIAISON PLEX GASTROINTESTINAL FLEX ASSAY:

  • IS THE INDUSTRY'S MOST COMPREHENSIVE GASTROINTESTINAL SYNDROMIC TESTING PANEL, INCLUDING 24

    GASTROINTESTINAL PATHOGEN TARGETS

  • IS A FULLY CUSTOMIZABLE PANEL, WHICH SUPPORTS DIAGNOSTIC STEWARDSHIP, ACCELERATES TURNAROUND TIMES, AND HELPS CONTROL HEALTHCARE COSTS

  • completes the core LIAISON PLEX panel portfolio, together with the respiratory FLEX and three blood culture panels, further strengthening Diasorin's menu and enhancing its positioning in the multiplexing segment

Saluggia, Italy - May 19, 2026 - Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the LIAISON PLEX Gastrointestinal Flex Assay, a fully customizable syndromic testing panel capable of detecting a market-leading 24 gastrointestinal pathogen targets. The new panel expands Diasorin's growing LIAISON PLEX assay portfolio, which also includes a customizable respiratory assay and three blood culture panels.

The LIAISON PLEX Gastrointestinal Flex Assay rapidly detects a wide range of gastrointestinal pathogens, including bacterial, viral, and parasitic targets, empowering clinicians to make timely, targeted treatment decisions. Unlike other sample-to-answer molecular solutions, the Diasorin panel provides truly comprehensive coverage, with particularly broad detection of clinically relevant parasites including Microsporidia, Dientamoeba fragilis, and Strongyloides stercoralis.

Using Diasorin's proprietary Flex Software, laboratories can tailor testing panels based on seasonality, clinical presentation, current clinical guidelines, recent patient travel history, or immune status. This flexibility allows healthcare teams to design fully customized panels and pay only for the targets they choose, helping to reduce unnecessary testing, support more informed treatment decisions, and improve patient management while enhancing healthcare operational efficiency. The flexibility becomes even more relevant for a broad gastrointestinal panel which includes 24 targets where target selection can align testing with the patient's specific clinical scenario.



"While clinical guidelines support testing based on patient presentation, current technologies often force laboratories to choose bet

een panels that are either too narro or too broad," said Angelo Rago, President of Luminex. "Diasorin's LIAISON PLEX Gastrointestinal Flex Assay addresses this challenge ith a value-driven solution that delivers fast, accurate results ith the flexibility needed to optimize diagnostic ste ardship, help improve patient outcomes, and manage healthcare costs more effectively."

The LIAISON PLEX Gastrointestinal Flex Assay joins Diasorin's menu of FDA-cleared flexible syndromic tests, including the LIAISON PLEX Respiratory Flex Assay, LIAISON PLEX Yeast Blood Culture Assay, LIAISON PLEX Gram-Negative Blood Culture Assay, and LIAISON PLEX Gram-Positive Blood Culture Assay. This panel portfolio meets the main laboratory needs for syndromic molecular testing and further strengthens Diasorin's positioning in this technology segment.

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 30 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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