Roche Secures CE Mark For AI Kidney Klinrisk Tool, Launches Comprehensive Chronic Kidney Disease Algorithm Panel

Roche, in partnership with KlinRisk, Inc., has received CE marking for the first AI-based risk stratification tool designed to assess progressive kidney function decline. This approval enables Roche to launch the Chronic Kidney Disease (CKD) algorithm panel on its navify® Algorithm Suite, providing support across all stages of the CKD care pathway. The panel combines the newly CE-marked Kidney Klinrisk Algorithm, which enables early risk assessment for adults diagnosed with CKD as well as adults with diabetes or hypertension at elevated risk of kidney function decline, with the established CE-marked Kidney KFRE Algorithm (KFRE) for managing later stages of CKD.

Chronic kidney disease affects over 700 million people globally and is recognized as a major public health challenge. Early diagnosis and appropriate treatment can slow or prevent kidney function deterioration, reduce cardiovascular risks, and lower related healthcare costs. Matt Sause, CEO of Roche Diagnostics, stated that the Kidney Klinrisk Algorithm represents a significant advancement in managing this often silent and progressive disease. The panel is designed to support physicians in making more informed decisions, including assessing adults with diabetes and hypertension who are at elevated risk but not yet diagnosed with CKD.

The AI-based solution equips healthcare professionals with a comprehensive risk assessment tool to proactively manage CKD in both diagnosed and at-risk undiagnosed patients, including those in early, often asymptomatic stages. The algorithm integrates multiple input factors from routine blood and urine tests and aligns its recommendations with established clinical guidelines, helping clinicians deliver timely, informed care.

Available on the navify® Algorithm Suite, the new CKD panel is part of Roche’s broader strategy to provide digital health solutions for the increasing global burden of chronic kidney disease. The cloud-based platform integrates seamlessly with existing hospital systems, offering clinicians a single access point to order and view algorithm results. The panel is currently available in Europe and the United Kingdom, with plans for future launches in the United States, the Middle East, and Asia.