India Pharma Outlook Team | Tuesday, 07 October 2025
Roche and KlinRisk have announced that they received a CE mark for the Kidney Klinrisk Algorithm, the first AI-based risk stratification tool for determining progressive decline in kidney function.
The CE mark for the Kidney Klinrisk Algorithm represents a substantial step forward in providing digital solutions for managing kidney disease.
The Kidney Klinrisk Algorithm is to be incorporated into Roche’s Chronic Kidney Disease (CKD) Algorithm Panel on the navify Algorithm Suite. The CKD Algorithm Panel will support clinical decision-making for CKD across all stages of the disease.
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“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.”
The CKD Algorithm Panel consists of the new CE-marked Kidney Klinrisk Algorithm, which is for early risk assessment of adults diagnosed with CKD, as well as adults with diabetes or hypertension at elevated risk of progressive decline in kidney function, and the previously available established Kidney KFRE Algorithm (KFRE) for late-stage management of CKD.
Chronic kidney disease is a significant global public health issue, impacting over 700 million people worldwide. Early diagnosis and timely intervention are essential to delaying or preventing the disease progression, reducing risk of cardiovascular events, and minimizing the burden of care.
With this launch, Roche recommits to the use of advanced digital technologies and use of artificial intelligence to improve patient outcomes and support the global efforts for reducing chronic kidney disease impacts.
