Renalytix Plc Regulatory News (RENX)

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. 

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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.