RE: Welcome to Renalytix4 Nov 2025 11:07
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
www.renalytix.com
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. kidneyin
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