Precision medicine diagnostics company Renalytix plc (LSE: RENX) (OTCQB: RNLXY) announced on Wednesday the publication of a pivotal study on its FDA-approved and Medicare-reimbursed kidneyintelX.dkd test in Diabetes Care, the flagship journal of the American Diabetes Association.

The study, titled 'Baseline Risk and Longitudinal Changes in kidneyintelX.dkd and Its Association With Kidney Outcomes in the CANVAS and CREDENCE Trials', analysed data from 2,954 subjects across both trials. Results showed that kidneyintelX.dkd improved risk classification across all KDIGO-defined groups and identified patients most responsive to SGLT2 inhibitor therapy, with high-risk treated patients twice as likely to show reduced risk after one year. Authors concluded that the test enables personalised risk assessment and monitoring in clinical practice.

Publication of these findings coincided with three presentations at the American Society of Nephrology's Kidney Week, held in Houston, Texas from 5 - 9 November 2025. The abstracts highlighted successful large-scale implementation of kidneyintelX.dkd, its positive impact on provider and patient engagement and its superior predictive accuracy compared to the Kidney Failure Risk Equation in diabetic kidney disease.

Together, these data reinforce kidneyintelX.dkd as a precision medicine standard for early-stage risk assessment and management of chronic kidney disease.

Renalytix, headquartered in the US and the UK, develops AI-enabled in vitro diagnostics to optimise kidney disease management. With full Medicare reimbursement at USD950 per reportable result, kidneyintelX.dkd is now commercially deployed across major US health systems, supported by growing real-world evidence in over 15,000 tested patients.