CE Mark RNS YEEHAAA1 Oct 2025 07:04
CE Mark application submission
In response to strategic partner interest in use of kidneyintelX.dkd in a clinical trial in Europe
LONDON and NEW YORK, 1 October 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a precision medicine diagnostics company, with kidneyintelX.dkd, the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment in chronic kidney disease, announces that it has submitted an application for CE Mark certification in accordance with the European Union In-Vitro Diagnostics Regulation (IVDR) to enable clinical use and reporting of the kidneyintelX.dkd™ test across the EU.
The kidneyintelX.dkd prognostic blood test is commercially available in the US and indicated for use as an aid in predicting level of risk (high, moderate, low) for progressive decline in kidney function in type 2 diabetes patients with diagnosed chronic kidney disease stages 1-3b.
Renalytix is pursuing a CE mark in response to growing international strategic partner interest, having already entered in discussions with a Top 10 global pharmaceutical company on the use of the test for targeted enrollment of patients in a global clinical trial and potential use as a companion diagnostic for a novel therapy. When combined with FDA approval, the CE Mark will further embed kidneyintelX.dkd as the global precision medicine standard in Chronic Kidney Disease (CKD).
On successful achievement of a CE mark, expected in H1 2026, Renalytix anticipates further commercial opportunities, including international distribution partnerships, in FY26 and/or FY27.
According to independently published estimates, CKD is a significant global health issue affecting nearly 850 million people globally with close to 100 million of those being European individuals.
A diagnostic blood test requires CE mark certification which is subject to a rigorous assessment of data on safety, analytical validation, software controls and clinical performance in compliance with IVDR.