REG - Renalytix PLC - CE Mark application submission

RenalytixAnnouncement

01/10/2025 07:00

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RNS Number : 4841B  Renalytix PLC  01 October 2025

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                                     www.renalytix.com (http://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
                                                   (mailto: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 (http://kidneyintelx.com/) .

 

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