CE Mark application submission
Summary by AI BETAClose X
Renalytix plc
("Renalytix" or the "Company")
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.
For further information, please contact:
|
Renalytix plc |
||
|
James McCullough, CEO |
Via Walbrook PR |
|
|
|
|
|
|
SP Angel Corporate Finance LLP (Nominated Adviser and Joint Broker) |
Tel: +44 (0)20 3470 0470 |
|
|
Jeff Keating / David Hignell (Corporate Finance) Vadim Alexandre (Corporate Broking) |
|
|
|
|
|
|
|
Oberon Capital (Joint Broker) |
Tel: +44 (0)20 3179 5300 |
|
|
Mike Seabrook / Nick Lovering |
|
|
|
|
|
|
|
Walbrook PR Limited |
Tel: 020 7933 8780 or renalytix@walbrookpr.com |
|
|
Paul McManus / Alice Woodings |
Mob: 07980 541 893 / 07407 804 654 |
|
About Renalytix (www.renalytix.com)
Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes. Renalytix has received FDA approval and Medicare reimbursement for kidneyintelX.dkd which is now offered commercially in the United States.
Unrecognized and uncontrolled kidney disease remains one of the largest barriers to controlling cost and suffering in the United States and the United Kingdom's medical system, affecting over 14 million and 8 million people, respectively. After five years of development and clinical validation, kidneyintelX.dkd is the only FDA-approved and Medicare reimbursed prognostic tool capable of understanding a patient's risk with kidney disease early where treatment has maximal effect. kidneyintelX.dkd is now being deployed across large physician group practices and health systems in select regions of the United States.
The over 15,000 patients that have been tested by kidneyintelX.dkd have produced a substantial body of real-world performance data. In patient populations where kidneyintelX.dkd has been deployed, a demonstrated and significant increase in diagnosis, prognosis, and treatment rates have been recorded. kidneyintelX.dkd now has full reimbursement established by Medicare, the largest insurance payer in the United States, at $950 per reportable result. kidneyintelX.dkd is also recommended for use in the international chronic kidney disease clinical guidelines (KDIGO).
KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to Renalytix AI, Inc. Mount Sinai faculty members are co-founders and equity owners in the Company. In addition, the Icahn School of Medicine at Mount Sinai has equity ownership in Renalytix. For information about the kidneyintelX,dkd test, visit kidneyintelx.com.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.
Latest directors dealings
- 28 minutes ago Morgan Sindall Group
- 3 hours ago River Global Plc
- 4 hours ago Pipehawk
- 4 hours ago Frasers Group
- 4 hours ago DP Aircraft I Limited Pref