KidneyIntelX™ included in KDIGO 2024 Guideline

Guidelines highlight the importance of risk prediction and personalized treatment to reduce risk

LONDON and SALT LAKE CITY, March 14, 2024 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX) (Renalytix) announces that the KidneyIntelX In-Vitro Diagnostic test has been included in the final KDIGO (Kidney Disease Improving Global Outcomes) 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD), published on March 13, 2024. In the release of the new guideline, timed to coincide with World Kidney Day on March 14, the KDIGO committee highlighted the role of risk prediction in guiding care for patients. In this context, KidneyIntelX is recommended for use as an externally validated tool for predicting disease progression in people with CKD stages G1-G3.

The Guideline Work Group recognized that the progression of CKD can occur at all stages, and that in earlier stages of disease (G1-G3), understanding the risk of 40% decline in kidney function over a short term 5 years, as per the indicated use of KidneyIntelX, is important for guiding early intervention, particularly in people at intermediate or high risk for progression. Renalytix received FDA de-novo marketing authorization for kidneyintelX.dkd in June 2023 for use in assessment of the risk of progressive decline in kidney function in patients with CKD stages G1-G3 and Type 2 Diabetes.

Subsequent to the release of the draft content of this updated guideline in July 2023, further evidence has been published from clinical utility and outcomes studies with a current enrollment of more than 9,000 patients with Type 2 Diabetes and CKD G1-G3. In January 2024, published outcomes data from an analysis of more than 2,500 patients with one year of follow-up demonstrated that providing clinicians access to KidneyIntelX risk assessment to inform care was associated with clinical actions that resulted in sustained reduction in eGFR decline, improved diabetes management and improved cardiovascular health.

In the KDIGO announcement of the publication of the 2024 CKD guideline, Adeera Levin MD, one of the Guideline Committee Co-Chairs said, "Recent advancements in GFR evaluation, risk prediction, and the arrival of novel treatments are poised to enhance CKD prognosis and management. We also hope the guideline's emphasis on multidisciplinary teamwork, patient engagement, and a holistic, evidence-based approach to care will help catalyze positive change, resulting in more coordinated CKD care management worldwide. By integrating the latest evidence and expert consensus, we aim to empower healthcare professionals, and patients with actionable recommendations to optimize patient outcomes and enhance quality of life."

Commenting on the guideline release Michael J. Donovan, PhD, MD, Chief Medical Officer at Renalytix stated, "Patients with type 2 diabetes and CKD are benefitting from the evidence gathered from a number of recent clinical trials and access to accurate risk assessment to inform care in a significant and growing healthcare challenge in the United States and globally. Renalytix welcomes these new updates from KDIGO which provide for clear and timely treatment strategies for health care professionals and we look forward to continuing to release evidence to highlight the role that KidneyIntelX is playing achieving the goal of optimizing patients' outcomes and enhancing quality of life."

About Type 2 Diabetes

Sources

2 https://www.cdc.gov/diabetes/basics/type2.html

3 https://www.cdc.gov/diabetes/data/statistics-report/index.html

4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/