Renalytix plc

("Renalytix" or the "Company")

kidneyIntelX.dkd Published in Journal of the American Society of Nephrology

LONDON and NEW YORK, 6 February 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), which is commercialising kidneyintelX.dkd, the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment for chronic kidney disease, notes the publication of the paper kidneyintelX.dkd: An Innovation in Precision Medicine for Diabetic Kidney Disease in the Journal of the American Society of Nephrology (JASN), the leading journal in the advancement of understanding and treatment of kidney diseases. 

The paper, published by invitation for dissemination of innovative technologies, highlights kidneyintelX.dkd as a critical risk assessment tool to enable a personalised approach to treatment and identification of those who would benefit most from multifaceted therapy to slow the progression of DKD.

The publication also discusses the inclusion of kidneyintelX.dkd in the recently published KDIGO guidelines, which recommends "risk assessment to assist with delivery of personalized care for people with CKD":

"With multiple new drug classes now available for DKD management in addition to baseline RAAS inhibition, precision medicine solutions such as kidneyintelX.dkd can change the current paradigm to a more individualized approach. Some experts advocate an 'accelerated risk-based approach' in which prioritization for 'quadruple therapy' is reserved for those at highest absolute risk for progression, given costs and potential adverse events."

This is particularly relevant with the recent regulatory approvals of Ozempic® for treatment of DKD, further fuelling the need for an accelerated risk-based approach targeting those at the highest risk of progression, thereby ensuring the best possible health outcomes and avoiding unnecessary, expensive treatments for those at lower risk.  

Fergus Fleming, Chief Technology Officer of Renalytix, commented:

"The age of precision medicine in chronic disease is just beginning and will be central to preventative care, improved patient outcomes, and control of spiralling healthcare costs.  We welcome the publication of the kidneyintelX.dkd innovation in this prestigious journal which will help to better inform the nephrology and wider healthcare community on the power and utility of biomarker -based early risk assessment with kidneyintelX.dkd.

"With multiple new drugs coming into wider use in the clinic, including Novo Nordisk's achievement this month securing approval for Ozempic for the treatment of DKD, the ability to accurately understand a patient's disease risk is paramount. We have invested over six years developing kidneyintelX.dkd to deliver an accurate, FDA regulated, Medicare reimbursed prognosis directly to physicians charged with making timely therapeutic decisions."

The full text of the publication will be available here in due course: https://www.kidneyintelx.com/evidence/

For further information, please contact:

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 10,000 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). 

Disclosure: KidneyIntelX is based on innovative technology developed by Mount Sinai faculty and licensed to Renalytix.  Mount Sinai faculty-inventors and Mount Sinai have equity ownership in Renalytix.