DiaSorin’s COMBI Study Targets Smarter Gut Diagnostics and Future Growth

DiaSorin S.p.A. (GB:0GZX) announced an update on their ongoing clinical study.

The COMBI study from DiaSorin Inc. collects samples and data to assess a new stool test that may better distinguish inflammatory bowel disease from irritable bowel syndrome versus current methods. The official title highlights a multi-center evaluation of the LIAISON Calprotectin HD biomarker combination, which could improve diagnosis and reduce invasive procedures.

The main intervention is a lab-based stool test using the LIAISON Calprotectin HD biomarker combination, designed to be run alongside standard care. Its purpose is to show whether this new test can sort patients more accurately, and possibly cut back on unnecessary colonoscopies and related costs.

The study is observational and prospective, meaning patients receive only routine care while their data and samples are tracked over time. There is no random assignment or blinding; instead, outcomes from the new test are compared to colonoscopy and other clinical findings in both healthy and symptomatic groups.

The research follows two main cohorts, one of healthy subjects and another of patients with ongoing gut symptoms under evaluation for possible inflammatory bowel disease. By comparing test performance across these groups, the design aims to show how well the new biomarker panel works in everyday clinical settings.

The study was first submitted on 10 March 2026, marking the formal public launch on the clinical registry. The same date is listed as the most recent update, signaling a fresh protocol and signaling that sites are ramping up enrollment.

The trial is currently enrolling by invitation, which often reflects a targeted site strategy and controlled rollout in select centers. Primary and final completion dates have not been posted yet, so investors should expect data to emerge over a multi-year horizon rather than in the near term.

For DiaSorin S.p.A., this study supports its broader diagnostics strategy and could add a differentiated product in gastrointestinal testing, a segment with steady demand. A successful readout may improve pricing power, expand lab contracts, and support sentiment for GB:0GZX, especially if payers see clear savings from fewer invasive procedures.

Competition includes existing fecal calprotectin tests and broader GI diagnostic panels from large players like Abbott and Roche, but a high-definition biomarker combo with strong data could carve out a premium niche. In the meantime, the study update mainly reinforces DiaSorin’s innovation pipeline rather than driving immediate revenue, making it a medium-term catalyst for investors.

The COMBI study is currently ongoing and recently updated, with further details available on the ClinicalTrials portal.