Precision medicine diagnostics company Renalytix plc (LSE: RENX) (OTCQB: RNLXY) announced on Wednesday that it has submitted an application for CE Mark certification under the EU In-Vitro Diagnostics Regulation (IVDR) to enable clinical use of its kidneyintelX.dkd test across Europe.

KidneyIntelX.dkd, already FDA-approved and reimbursed by Medicare in the US, is the only prognostic test supporting early-stage risk assessment for chronic kidney disease (CKD) in type 2 diabetes patients with stages 1-3b CKD. More than 15,000 patients have been tested in the US, generating real-world data showing significant improvements in diagnosis, prognosis, and treatment rates.

The submission follows growing international interest, including discussions with a Top 10 global pharmaceutical company on using kidneyintelX.dkd for patient selection in a clinical trial and as a potential companion diagnostic for a novel therapy. CE Mark approval is expected in H1 2026, with commercial opportunities and distribution partnerships anticipated in FY26 and FY27.

CKD affects around 850 million people worldwide, including nearly 100 million in Europe. Renalytix said achieving CE certification, combined with FDA approval, would further establish kidneyintelX.dkd as a global precision medicine standard in CKD management.