Pivotal kidneyintelX.dkd Data Published in Diabetes Care, Considered the Leading Clinical Journal Worldwide in Diabetes

New results and three presentations at ASN Kidney Week underscore kidneyintelX.dkd as a precision-medicine standard for CKD

NEW YORK, Nov. 18, 2025 /PRNewswire/ -- Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a precision-medicine diagnostics company for kidney health and developer of kidneyintelX.dkd, the only FDA-approved and Medicare-reimbursed prognostic test for early-stage risk assessment in chronic kidney disease (CKD), announced the publication of pivotal new data in Diabetes Care, the top-ranked global diabetes journal of the American Diabetes Association.

The published manuscript, "Baseline Risk and Longitudinal Changes in kidneyintelX.dkd and Its Association with Kidney Outcomes in the CANVAS and CREDENCE Trials," was authored by leading nephrology and metabolism experts from the US, Europe, and Australia. The study evaluated 2,954 patients from the landmark CANVAS and CREDENCE trials—representing the full intended-use population for kidneyintelX.dkd.

Key Findings

• Improved CKD risk prediction: kidneyintelX.dkd significantly enhanced risk stratification across all KDIGO guideline categories, delivering more accurate assessment of CKD progression risk and potential kidney failure.
  
  
• Actionable treatment guidance: Among patients classified as moderate or high risk, those treated with frontline SGLT2 inhibitors showed a significant reduction in kidneyintelX.dkd risk levels at one year, with high-risk patients twice as likely to show risk improvement compared with untreated patients.

The authors concluded that kidneyintelX.dkd, and its novel kidney biomarkers, enables clinicians to identify patients most likely to benefit from therapy, supporting personalized risk-based care today and offering a powerful tool for future clinical trials.

Expert Perspective

Associate Professor Brendon Neuen of The George Institute for Global Health, Sydney, an internationally recognizedexpert in cardio-kidney-metabolic health and co-author of the study, 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. These data provide a compelling example of how we can build on well-established clinical parameters to deliver more personalized care and reduce the risk of adverse outcomes."

Dr. Neuen serves as Program Lead, Renal & Metabolic at The George Institute and Director of Kidney Trials at Royal North Shore Hospital.

kidneyintelX.dkd Spotlighted in Three Presentations at ASN Kidney Week 2025

Renalytix also presented three new abstracts at ASN Kidney Week in Houston
(Nov 5–9), highlighting real-world implementation, clinical utility, and performance advantages of kidneyintelX.dkd:

1. PO0330 — Implementation in a Large Integrated Health System

Demonstrated a scalable framework for deploying kidneyintelX.dkd to drive sustained population-level adoption and deliver personalized improvements in care management across a major US health network.

2. PO0331 — Decision-Impact Study in Community Practice  

• 87% of patients reported better understanding of their kidney risk.
• 98% said the test improved their understanding of kidney health and its importance.
• 86% of physicians said kidneyintelX.dkd directly influenced care decisions.

3. PO0332 — Superior Prediction vs. KFRE  

kidneyintelX.dkd outperformed the Kidney Failure Risk Equation (KFRE) in predicting kidney function decline or kidney failure in diabetic kidney disease, demonstrating superior discrimination and reliability, especially in early-stage disease.

Setting a New Standard in CKD Precision Medicine

Across clinical trials, real-world deployment, and head-to-head performance comparisons, kidneyintelX.dkd continues to show consistent, incremental value as a core component of precision medicine in CKD. These results support its role as a transformative tool in integrated care management—ultimately driving significant improvements in patient and health outcomes.

About Chronic Kidney Disease: a worldwide public health crisis

Chronic Kidney Disease is a worldwide public health crisis impacting 850 million individuals worldwide. According to the National Kidney Foundation, it is estimated to impact more than 35 million adults in the United States and 90% of those do not know they have it, with Medicare spending over $130 billion annually to care for those with kidney disease and kidney failure.

About Renalytix

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.

To learn more about Renalytix, visit renalytix.com, and for information about the kidneyintelX.dkd test, visit kidneyintelx.com.

For further information, please contact:

SOURCE Renalytix plc