Roche receives CE mark for AI-based kidney Klinrisk agorithm

Roche, 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, alongside the established CE-marked Kidney KFRE Algorithm for managing later disease stages of CKD.

The Kidney Klinrisk Algorithm, an in vitro diagnostic medical device software, is a machine learning (ML)-based tool to aid clinicians in making more informed, precise decisions on progressive kidney function decline. The algorithm is intended to be applied to adults diagnosed with CKD in stages G1 to G4, and to diabetic and/or hypertensive adults who are at risk for CKD.

The Kidney Klinrisk Algorithm was developed in collaboration with Klinrisk Inc, a medical AI company founded by Dr. Navdeep Tangri, a leading physician in kidney health, building multiple prognostic tests for cardiovascular, kidney, and metabolic conditions to address the needs of patients, providers, and health systems.

Healthcare professionals now have easy access to a comprehensive risk assessment solution for managing CKD proactively in both diagnosed and undiagnosed adults at risk, including in the early, often asymptomatic stages of the disease. This AI-based solution combines multiple input factors from routine blood and urine tests and aligns recommendations with clinical guidelines.

The new CKD algorithm panel marks a significant step in Roche’s strategy to provide digital health solutions for the growing global burden of chronic kidney disease. This cloud-based platform seamlessly integrates with existing hospital systems, giving clinicians a single point of access to order and view algorithm results.

The panel is available in Europe and the United Kingdom, with a later launch in the United States, the Middle East, and Asia.

"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," he added.

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