Roche announced it has received CE mark approval for the Kidney KlinRisk Algorithm, marking the first AI-based risk stratification tool designed to assess progressive decline in kidney function. The milestone enables the company to launch a comprehensive chronic kidney disease (CKD) algorithm panel on its navify Algorithm Suite, addressing a condition that affects more than 700 million people worldwide.
The new CKD algorithm panel combines the novel Kidney KlinRisk Algorithm with the established CE-marked Kidney KFRE Algorithm to support care across all stages of chronic kidney disease. The KlinRisk component specifically targets 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.
Addressing Early Detection Challenges
Currently, no single biomarker test can predict an elevated risk of CKD, creating significant challenges in early detection and intervention. The machine learning-based Kidney KlinRisk Algorithm was developed in collaboration with KlinRisk Inc to predict CKD before symptom onset, combining multiple input factors from routine blood and urine tests while aligning recommendations with clinical guidelines.
"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 of 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."
Clinical Impact and Healthcare Economics
With early diagnosis and appropriate treatment, it is possible to delay or prevent kidney function decline, and reduce cardiovascular risk and related healthcare costs. CKD represents a major healthcare cost driver, accounting for up to 2-3% of annual healthcare budgets. The condition increases hospitalizations, cardiovascular disease risk, and can lead to early mortality, yet adherence to guideline-directed medical therapies often remains below target levels.
The rising incidence of CKD is fueled by increasing cases of diabetes, hypertension, and obesity worldwide. In its early stages, CKD is often asymptomatic, leaving many people unaware they have the condition. If left untreated, CKD can progress to kidney failure, requiring dialysis or kidney transplant.
Technology Integration and Availability
The CKD algorithm panel is available on Roche's navify Algorithm Suite, a cloud-based platform that seamlessly integrates with existing hospital systems. This integration provides clinicians with a single point of access to order and view algorithm results, supporting proactive management of both diagnosed and undiagnosed adults at risk.
The Kidney KlinRisk Algorithm is classified as an in vitro diagnostic medical device software, intended for application to adults diagnosed with CKD in stages G1 to G4, and to diabetic and/or hypertensive adults who are at risk for CKD. The algorithm was developed in collaboration with KlinRisk Inc, a medical AI company founded by Dr. Navdeep Tangri, a leading physician in kidney health.
Market Rollout Strategy
The panel is currently available in Europe and the United Kingdom, with planned launches in the United States, the Middle East, and Asia. The navify platform operates with ISO/IEC 27001 certification for Information Security Management Systems, ensuring data encryption at rest and in transit while maintaining compliance with HIPAA regulations in the USA and GDPR regulations in Europe.
This launch represents a significant step in Roche's strategy to provide digital health solutions for the growing global burden of chronic kidney disease, offering healthcare professionals comprehensive risk assessment capabilities for managing CKD proactively across all disease stages.
