REG - Renalytix PLC - Pivotal kidneyintelX.dkd data published

RenalytixAnnouncement

12/11/2025 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20251112:nRSL1442Ha&default-theme=true

RNS Number : 1442H  Renalytix PLC  12 November 2025

Renalytix plc

("Renalytix" or the "Company")

 

Pivotal kidneyintelX.dkd data published in Diabetes Care Journal of the
American Diabetes Association

 

Presentation of 3 abstacts highlighting clinical utility  at American Society
of Nephrology Kidney Week

 

LONDON and NEW YORK, 12 November 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 a manuscript
titled "Baseline Risk and Longitudinal Changes in kidneyintelX.dkd and Its
Association With Kidney Outcomes in the CANVAS and CREDENCE Trials" has been
published in the highest ranked diabetes journal globally, Diabetes Care, from
the American Diabetes Association.

 

The study was co-authored by global thought leaders from Europe, US and
Australia and included analysis of the kidneyintelX.dkd test in a combined
cohort of 2,954 subjects from the completed CANVAS and CREDENCE clinical
trials meeting the intended use of the test. Among a number of significant
findings reported, are the following:

 

-      kidneyintelX.dkd provides improved risk classification across all
of the established risk groups as presented in the KDIGO clinical guidelines

 

-      Treatment with SGLT2i front line therapy in patients classified as
moderate or high risk by kidneyintelX.dkd resulted in a significant risk
reduction, with the high risk treated group twice as likely to reduce their
kidneyintelX.dkd risk level at 1 year compared to those not receiving
treatment.

 

The authors concluded that kidneyintelX.dkd facilitated the identification of
patients most likely to respond to therapy through personalized risk
assessment with the potential for monitoring in clinical practice and a role
in future clinical studies.

 

Associate Professor Brendon Neuen of The George Institute for Global Health,
Sydney, who co-authored the paper, commented: "With multiple recent
breakthroughs in therapies to reduce kidney function decline, the time for
risk-based implementation in CKD has arrived. Incorporating novel biomarkers,
as done with kidneyintelX.dkd, holds strong promise to guide risk-based care.
 The data published in this study provides a compelling example of how we can
build on well established clinical parameters to deliver more personalized
care and reduce the risk of adverse clinical outcomes."

 

Associate Professor Brendon Neuen is an internationally recognised expert on
cardio-kidney-metabolic health. He is Program Lead, Renal and Metabolic at The
George Institute for Global Health and a Staff Specialist Nephrologist and
Director of Kidney Trials at Royal North Shore Hospital (full biography
available below).

 

This most recent kidneyintelX.dkd publication co-incides with the presentation
of three abstracts at ASN Kidney Week, held in Houston Texas from November
5-9.  A summary of these abstract are as follows;

 

1.    PO0330: Successful Implementation of KidneyIntelX in a Large
Integrated Health System for Risk-Based Management of Diabetic Kidney Disease

 

The abstract highlighted a framework for deployment of kidneyintelX.dkd and
precision medicine into a large integrated health system to achieve sustained
population and patient level adoption, thereby eliciting personalised
improvements in care management.

 

2.    PO0331: Decision Impact Study of kidneyintelX.dkd on provider
management and patient engagement in a community care practice environment

 

87% of patients reported improved understanding of their kidney risk and 98%
found the kidneyintelX.dkd test helped in understanding their kidney and
importance of overall health. 86% of physicians in this community setting
reported the test result informed care management decisions.

 

3.    PO0332: Comparison of kidneyintelX.dkd and KFRE for Predicting
Progression of Diabetic Kidney Disease

 

The kidneyintelX.dkd test outperformed the Kidney Failure Risk Equation (KFRE)
in predicting decline in kidney function or kidney failure in patients with
DKD. The demonstrated improved discrimination and performance of
kidneyintelX.dkd compared with the known variability in the KFRE routine
clinical features,  highlighted the utility of the kidneyintelX.dkd test,
particularly in early stage disease.

 

Taken together, these data presentations reinforce the incremental and
consistent value of the kidneyintelX.dkd test as a standard for precision
medicine in CKD, and as a core element of integrated care management across
multiple health care settings ultimately, driving significant improvements in
patient care and health outcomes.

 

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: +44 (0)20 7933 8780 or renalytix@walbrookpr.com
                            (mailto:renalytix@walbrookpr.com)
 Paul McManus / Alice Woodings                         Mob: +44 (0)7980 541 893 / +44 (0)7407 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/) .

 

About A/Prof Brendon Neuen

Associate Professor Brendon Neuen is Program Lead, Renal and Metabolic at The
George Institute for Global Health and a Staff Specialist Nephrologist and
Director of Kidney Trials at Royal North Shore Hospital. He graduated in
medicine at James Cook University with 1st Class Honours and an Academic
Medal; completed a Masters in Global Health and Epidemiology from the
University of Oxford; a PhD from the University of New South Wales; and a
Postdoctoral Fellowship at Brigham and Women's Hospital, Harvard Medical
School. He is a Fellow of the Royal Australasian College of Physicians and a
Fellow of the American Society of Nephrology.

 

He is an internationally recognised expert on cardio-kidney-metabolic health
and serves as the Secretariat (Co-Chair) of the SGLT2 Inhibitor Meta-Analysis
Cardio-Renal Trialists' Consortium (www.SMART-C.net (http://www.SMART-C.net)
), which brings together data from over 90,000 patients from large-scale
randomized trials to better understand the effects of this class of medicine
in major patient groups. In addition, A/Prof Neuen is involved in the
leadership of multiple ongoing international multi-centre randomized trials
evaluating treatments to prevent kidney failure, cardiovascular events, or
both. His work has directly informed more than 30 major international and
national clinical practice guidelines, position papers and scientific
statements which define best practice for the care of people with chronic
kidney disease, including the Kidney Disease Improving Global Outcomes (KDIGO)
Guidelines and the American Diabetes Association (ADA) Standards of Care.

 

A/Prof Neuen is the author of over 150 peer-reviewed publications in general
medical journals including The Lancet, JAMA and Nature Medicine, and specialty
journals including Lancet Diabetes and Endocrinology, Circulation, and the
Journal of the American Society of Nephrology. He serves on the Editorial
Boards of flagship journals of the American Society of Nephrology and European
Renal Association. His work is supported by the National Health and Medical
Research Council of Australia, New South Wales Health, the Ramaciotti
Foundation, as well as philanthropic sources, and has been recognised through
multiple awards, including the Royal Society of New South Wales Ida Browne
Medal, and the American Heart Association's Paul Dudley White International
Scholar Award.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  RESFFMESFEISEFF



            Copyright 2019 Regulatory News Service, all rights reserved