REG - Renalytix PLC - Tempus AI Inc, collaboration agreement

RenalytixAnnouncement

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RNS Number : 3043Z  Renalytix PLC  15 September 2025

 

This announcement contains inside information for the purposes of Article 7 of
the Market Abuse Regulation (EU) 596/2014 as it forms part of UK domestic law
by virtue of the European Union (Withdrawal) Act 2018 ("MAR"), and is
disclosed in accordance with the Company's obligations under Article 17 of
MAR.

 

Renalytix plc

("Renalytix" or the "Company")

 

Tempus AI Inc, collaboration agreement

 

Definitive agreement to accelerate adoption of kidneyintelX.dkd test

to slow kidney disease progression and improve patient outcomes

 

The kidneyintelX.dkd test to become more

widely available within the Tempus US network of healthcare institutions

 

LONDON and NEW YORK, 15 September 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
signed a collaboration agreement with Tempus AI, Inc. (NASDAQ: TEM)
("Tempus").

 

The collaboration will make kidneyintelX.dkd prognostic blood testing more
widely available for eligible patients within its US network of healthcare
institutions. Eligible patients have type 2 diabetes with chronic kidney
disease, impacting nearly 15 million individuals in the US.

 

Renalytix's kidneyintelX.dkd will be the first test offered in Tempus'
portfolio in the chronic kidney disease category, 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.

 

James McCullough, CEO of Renalytix, commented: "The unique Tempus platform,
with its broad clinical reach, will allow us to significantly expand patient
and clinician access to advanced kidneyintelX.dkd precision medicine testing
in one of the largest and costliest chronic disease conditions today. Further,
we expect our partnership to be instrumental in driving therapeutic and
diagnostic innovation through multi-modal data accumulation and analysis in
patients in the cardiovascular, renal and metabolic space."

 

Ryan Fukushima, Tempus Chief Operating Officer, said:

"We share Renalytix's mission of developing AI-enabled diagnostics designed to
support clinicians in surfacing new insights that can inform patient care.
This collaboration expands our reach into the diabetes and chronic kidney
disease space, and we look forward to bringing our technology to these
patients."

 

Under the agreement, Tempus and Renalytix will collaborate with US health
systems to make testing more available for providers to order within existing
clinical workflows.

 

The kidneyintelX.dkd tests will be processed in a Renalytix laboratory with
customized patient results reported electronically to the ordering clinician
and patient portal, where applicable. The test's insights allow for timely
changes in patient management, which can help providers mitigate progressive
decline in kidney function and improve key quality metrics in diabetes and
kidney care.

 

Tempus is a technology company advancing precision medicine through the
practical application of artificial intelligence in healthcare. With one of
the world's largest libraries of multimodal data, and an operating system to
make that data accessible and useful, Tempus provides AI-enabled precision
medicine solutions to physicians to deliver personalized patient care and in
parallel facilitates discovery, development and delivery of optimal
therapeutics. The goal is for each patient to benefit from the treatment of
others who came before by providing physicians with tools that learn as the
company gathers more data. For more information, visit tempus.com
(https://www.tempus.com/) .

 

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.

 

 

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