Roche in partnership with KlinRisk, Inc., has received CE marking for the first artificial intelligence (AI)-based risk stratification tool designed to assess progressive kidney function decline. This approval enables Roche to introduce the Chronic Kidney Disease (CKD) Algorithm Panel on its navify® Algorithm Suite, enhancing clinical decision-making across all stages of CKD care.
The new panel features the Kidney Klinrisk Algorithm — an AI-driven tool for early risk assessment in adults with CKD, as well as in individuals with diabetes or hypertension who are at increased risk of kidney function deterioration. It complements the already CE-marked Kidney Failure Risk Equation (KFRE) Algorithm, which supports management during later stages of CKD.
Chronic kidney disease affects over 700 million people globally and is recognized as a major public health concern. Early identification and timely intervention can delay or prevent kidney failure, reduce cardiovascular complications, and lower overall healthcare costs.
“The launch of the AI-based Kidney Klinrisk Algorithm as part of our chronic kidney disease algorithm panel represents a significant advancement in the fight against this often silent, progressive disease,” said Matt Sause, CEO, Roche Diagnostics. “The panel is designed to support physicians to make more informed decisions and manage patients’ kidney function at every stage of the disease. Most importantly, this also includes the possibility to assess adults with diabetes and hypertension, who are at elevated risk for kidney function decline and not yet diagnosed with CKD.”
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With this development, healthcare providers gain access to a comprehensive AI-enabled solution for proactive CKD risk assessment — not only for diagnosed patients but also for those at risk who may still be asymptomatic. The system analyzes multiple data points from routine blood and urine tests and aligns its insights with established clinical guidelines, helping clinicians intervene earlier and more precisely.
Available through the navify® Algorithm Suite, the CKD algorithm panel integrates seamlessly into existing hospital information systems, providing a unified, cloud-based platform for ordering and reviewing algorithmic results. The solution is currently available in Europe and the United Kingdom, with future launches planned in the United States, the Middle East, and Asia.
The Kidney Klinrisk Algorithm is a machine learning (ML)-based in vitro diagnostic medical device software developed to assist clinicians in predicting and managing progressive kidney function decline. It is intended for use in adults diagnosed with CKD stages G1–G4, as well as in diabetic and hypertensive adults at risk for developing CKD.
Developed jointly with KlinRisk Inc., the algorithm reflects the work of Dr. Navdeep Tangri, a leading nephrologist and founder of KlinRisk. Dr. Tangri has pioneered several predictive models for cardiovascular, kidney, and metabolic health, aimed at improving outcomes for patients and supporting healthcare systems in managing chronic disease more effectively.
This milestone reinforces Roche’s commitment to advancing digital health technologies and AI-driven solutions that empower clinicians and transform patient care in chronic kidney disease management.