
Roche gets CE mark for chronic kidney disease algorithm
Roche Diagnostics and its partner KlinRisk Inc have received the EU CE mark for the very first AI-based risk stratification tool that reliably assesses progressive decline in kidney function.
Roche announced it will integrate the new AI-based risk stratification tool into its Chronic Kidney Disease (CKD) algorithm panel on its navify Algorithm Suite to support care across all stages of chronic kidney disease (CKD). The novel Kidney KlinRisk Algorithm carries out an early risk assessment of adults diagnosed with CKD, as well as adults with diabetes or hypertension who are at elevated risk for kidney function decline – alongside the established CE-marked Kidney KFRE Algorithm (KFRE) for managing later disease stages of CKD.
So far, there is no single biomarker test that can predict an elevated risk of CKD, a condition affecting more than 700 million people worldwide. 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 algorithm combines multiple input factors from routine blood and urine tests and aligns recommendations with clinical guidelines. The Kidney KlinRisk Algorithm is a machine learning (ML)-based tool that was developed in collaboration with KlinRisk Inc to predict CKD before symptom onset.