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Roche receives CE Mark for AI-based Kidney Klinrisk Algorithm(1) and launches new comprehensive chronic kidney disease (CKD) algorithm panel

Industry news | 08 October, 2025 | CACLP

Original from: Roche

 

Roche (SIX: RO, ROG; OTCQX: RHHBY), in collaboration with KlinRisk, Inc., has received the CE-mark for the first AI-based risk stratification tool to assess progressive decline in kidney function. This milestone allows Roche to introduce the Chronic Kidney Disease (CKD) algorithm panel on its navify® Algorithm Suite to support care across all stages of the CKD care pathway.  The panel includes the new Kidney Klinrisk Algorithm - for early risk assessment of adults diagnosed with CKD as well as adults with diabetes or hypertension at elevated risk for kidney function decline - alongside  the established CE-marked Kidney KFRE Algorithm (KFRE) for managing later disease stages of CKD.

 

Chronic kidney disease (CKD) affects more than 700 million people worldwide and is broadly recognized as a global public health challenge. With early diagnosis and appropriate treatment, it is possible to delay or prevent kidney function decline, and reduce cardiovascular risk and related 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."

 

Source: Roche receives CE Mark for AI-based Kidney Klinrisk Algorithm(1) and launches new comprehensive chronic kidney disease (CKD) algorithm panel

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