Roche’s AI-based kidney disease algorithm gains European certification

The new algorithm will be introduced as part of Roche’s CKD Algorithm Panelon thenavify Algorithm Suite

Roche in collaboration with KlinRisk announced that it has received the CE mark for the Kidney Klinrisk Algorithm, the first AI-based risk stratification tool for assessing progressive decline in kidney function. This achievement marks an important milestone in advancing digital solutions for kidney disease management.

The new algorithm will be introduced as part of Roche’s Chronic Kidney Disease (CKD) Algorithm Panelon thenavify Algorithm Suite, designed to support clinical decision-making across all stages of CKD. The panel includes both the newly CE-marked Kidney Klinrisk Algorithm—intended for early risk assessment of adults diagnosed with CKD, as well as adults with diabetes or hypertension at elevated risk of kidney function decline—and the established Kidney KFRE Algorithm (KFRE)for managing later stages of CKD.

Chronic kidney disease affects more than 700 million people worldwide and remains a major global public health challenge. Early diagnosis and timely intervention are key to delaying or preventing disease progression, reducing cardiovascular risk, and lowering the associated healthcare burden.

“The launch of the AI-based Kidney Klinrisk Algorithm as part of our CKD algorithm panel represents a significant step forward in the fight against this often silent and progressive disease,” said Matt Sause, CEO of Roche Diagnostics. “This comprehensive solution empowers physicians to make more informed clinical decisions and manage kidney health at every stage of the disease. Importantly, it also enables the early assessment of adults with diabetes and hypertension who are at increased risk of kidney function decline, even before a CKD diagnosis is established.”

With this launch, Roche reaffirms its commitment to leveraging advanced digital technologies and artificial intelligence to improve patient outcomes and support the global effort to reduce the impact of chronic kidney disease.