NEW YORK, June 30, 2026
Renalytix PLC has announced the publication of groundbreaking two-year real-world evidence (RWE) demonstrating that its FDA-approved KidneyIntelX® (kidneyintelX.dkd) precision diagnostic test delivers sustained clinical benefits for patients with type 2 diabetes and early-stage chronic kidney disease (CKD). Published in the peer-reviewed journal Diabetes, Obesity and Metabolism, the landmark prospective study evaluated 2,470 patients across Mount Sinai Health System and Wake Forest/Atrium Health, making it the company’s largest real-world analysis to date. The findings show that KidneyIntelX® not only improves risk stratification but also influences long-term clinical decision-making, increases uptake of guideline-directed medical therapies (GDMT), and significantly reduces patient risk trajectories over a 24-month period. The results represent a major advancement in precision medicine for diabetic kidney disease (DKD) by demonstrating that biomarker-guided care can improve kidney outcomes while helping clinicians personalize treatment strategies based on individual patient risk.
Two-Year Real-World Study Demonstrates Durable Clinical Benefits
The newly published study expands upon Renalytix’s earlier 6-month and 12-month real-world evidence programs, confirming that the benefits of KidneyIntelX® continue to strengthen over time. The latest 24-month analysis demonstrated that 29% of patients who underwent repeat testing moved into a lower kidney disease risk category, accompanied by measurable reductions in kidney injury biomarkers. Importantly, patients classified as high-risk at baseline were found to be 10.4 times more likely to experience significant kidney function decline or kidney failure than low-risk patients, highlighting the test’s exceptional prognostic performance.
Researchers also observed substantial improvements in key clinical indicators among high-risk patients, including a 43% improvement in estimated glomerular filtration rate (eGFR) decline, a 23% reduction in urinary albumin-to-creatinine ratio (UACR), and a 7.6% decrease in HbA1c, while blood pressure remained stable throughout the study period. These findings demonstrate that KidneyIntelX® functions as a dynamic longitudinal risk assessment tool rather than a single-point diagnostic test, allowing clinicians to monitor disease progression and treatment response more effectively.
Precision Diagnostics Improve Guideline-Directed Therapy Adoption
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One of the study’s most significant findings was the impact of KidneyIntelX® on physician decision-making and the adoption of guideline-directed medical therapy (GDMT). Following risk assessment, the use of SGLT2 inhibitors increased substantially across all patient risk groups, reaching 56% of high-risk patients overall and 70% among high-risk patients treated within Mount Sinai Health System. Combination therapy using SGLT2 inhibitors and GLP-1 receptor agonists nearly tripled, increasing from 12% to 32% over the two-year observation period.
Patients who initiated treatment with either SGLT2 inhibitors or GLP-1 receptor agonists were found to have nearly twice the likelihood of achieving measurable risk reduction, reinforcing the value of precision diagnostics in guiding evidence-based therapeutic decisions. These findings demonstrate how biomarker-guided care enables clinicians to deliver more intensive treatment to patients at highest risk while avoiding unnecessary therapy escalation for lower-risk individuals, advancing the practical implementation of precision medicine in routine nephrology and diabetes care.
AI-Driven Kidney Diagnostics Advance Precision Medicine
KidneyIntelX® combines artificial intelligence, blood-based biomarkers, and traditional clinical variables to identify patients at risk of progressive kidney disease earlier than conventional assessment methods. Already FDA-approved and eligible for Medicare reimbursement in the United States, the test supports physicians in identifying high-risk individuals who may benefit from earlier intervention before irreversible kidney damage occurs. As the global burden of diabetic kidney disease continues to rise, technologies capable of delivering accurate, individualized risk prediction are becoming increasingly important for improving patient outcomes while reducing healthcare costs.
The latest two-year real-world evidence reinforces Renalytix’s leadership in AI-enabled precision diagnostics and demonstrates that KidneyIntelX® has the potential to transform chronic kidney disease management by enabling earlier intervention, optimizing treatment selection, and improving long-term renal outcomes through personalized, data-driven clinical care.
Source: Renalytix press release
