Roche and KlinRisk have secured CE mark approval for their AI-driven risk stratification tool, designed for evaluating the progression of kidney function decline.
The new tool, a part of Roche's newly launched chronic kidney disease (CKD) algorithm panel, helps healthcare providers manage CKD at various stages.
Roche’s CKD panel features the Kidney Klinrisk Algorithm and the Kidney KFRE Algorithm.
It enables clinicians to assess the risk of kidney function deterioration, including during the early, often asymptomatic phases of the disease.
The Kidney Klinrisk Algorithm targets adults diagnosed with CKD, and those with diabetes or hypertension who are at increased risk of kidney function decline.
The Kidney KFRE Algorithm supports management in later stages of CKD.
Roche Diagnostics CEO Matt Sause said: “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.
“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.”
Roche is launching the new AI-based CKD panel on its navify Algorithm Suite.
The cloud-based platform integrates with existing hospital systems, providing a unified access point for clinicians to order and review algorithm outcomes.
Roche is initially launching the panel in Europe and the UK, with plans for future releases in the US, the Middle East and Asia.
The navify portfolio includes more than 130 digital solutions for laboratories, hospitals and patients globally, facilitating data integration and access to medical insights.
The platform prioritises data security, adhering to ISO/IEC 27001 standards and complying with Health Insurance Portability and Accountability and General Data Protection Regulation regulations.
Earlier this year, Roche secured CE mark approval for its Elecsys pTau181 test, developed in partnership with Eli Lilly and Company, to detect Alzheimer’s disease.
