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

Rhea-AI Summary

Roche (OTCQX: RHHBY) announced on 6 October 2025 that it has received a CE mark for the Kidney Klinrisk Algorithm, described in the PR as the first AI‑based risk stratification tool for progressive kidney function decline. According to the PR, Roche is launching a Chronic Kidney Disease (CKD) algorithm panel on its navify® Algorithm Suite that pairs the new Kidney Klinrisk Algorithm (early risk assessment) with the established CE‑marked Kidney KFRE Algorithm (later stage management).

The PR states the panel combines routine blood and urine inputs, aligns recommendations with clinical guidelines, is cloud‑based and integrates with hospital systems, and will be available in Europe and the UK at launch with later rollouts planned for the United States, Middle East, and Asia.

Positive

• Received CE mark for Kidney Klinrisk Algorithm (6 Oct 2025)
• Launch of CKD algorithm panel on navify Algorithm Suite
• Pairs AI early‑risk tool with established CE‑marked KFRE
• Panel available in Europe and UK at commercial launch

Negative

• No immediate availability in the United States (launch described as later)
• PR discloses no clinical performance metrics or validation numbers for the AI algorithm

• Roche, in collaboration with KlinRisk, Inc, has received CE-mark for the first AI-based risk stratification tool for assessment of progressive decline in kidney function.
• This tool will be launched as part of Roche’s new chronic kidney disease (CKD) algorithm panel to support care across the stages of the disease which affects 700 million people globally.
• Clinicians can use the CKD panel (Kidney Klinrisk Algorithm and Kidney KFRE Algorithm) to evaluate a patient’s risk of kidney function decline, including in the early asymptomatic stages of the disease.

Basel, 6 October 2025 - 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.² With early diagnosis and appropriate treatment, it is possible to delay or prevent kidney function decline, and reduce cardiovascular risk and related healthcare costs.^3,5,7

"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."

Supporting clinicians in early and proactive care
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, available on the navify® Algorithm Suite, 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.

About the Kidney Klinrisk Algorithm
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 Chronic Kidney Disease (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.

About chronic kidney disease
Chronic kidney disease (CKD) is a progressive condition characterized by a gradual loss of kidney function over time. In its early stages, CKD is often asymptomatic, and many people are unaware they have the condition. If left untreated, CKD can progress to kidney failure, requiring dialysis or a kidney transplant. CKD is closely linked to other chronic conditions such as diabetes and hypertension.

The rising incidence of CKD is fueled by increasing cases of diabetes, hypertension, and obesity worldwide and CKD can be a major healthcare cost driver representing up to 2-3% of the annual budgets.⁵ CKD increases hospitalizations, cardiovascular disease and can lead to early mortality.⁶ Still, adherence to guideline-directed medical therapies (GDMTs) is often below target use.

About navify
The navify portfolio from Roche includes more than 130 digital solutions for labs, hospitals and patients worldwide in commercial or research phases. navify solutions connect the healthcare community with a robust digital infrastructure to integrate data efficiently and to accelerate clinician access to innovations as well as operational and medical insights. This work includes collaborating with other innovative companies such as Fortinet in cybersecurity services. The navify platform is designed to deliver security at every step of the data analytical process with ISO/IEC 27001 certification for the Information Security Management System. All data is encrypted at rest and in transit. The solution is operated in compliance with applicable laws and regulations in the USA with HIPAA  (Health Insurance Portability and Accountability) as well as with GDPR (General Data Protection Regulation) regulations in Europe.

Healthcare professionals can visit navify Marketplace to browse and request a growing number of next generation digital solutions from Roche and other companies — all designed to drive operational and clinical excellence, built on the foundational pillars of digital trust. More information is also available at navify.com.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.
 

References
[1] European Union: EUR-Lex. Chronic Kidney Disease Algorithm Panel [Internet: accessed: August 2025] Klinrisk is an in-vitro diagnostic (IVD) medical device CE-marked (NB 0123)  under the requirements laid out in the IVD regulation (EU) 2017/746 (IVDR).
[2] GBD Chronic Kidney Disease Collaboration, Lancet (2020) https://doi.org/10.1016/S0140-6736(20)30045-3
[3] Shlipak, Kidney International (2021)  https://doi.org/10.1016/j.kint.2020.10.012
[4] Francis, A., Harhay, M.N., Ong, A.C.M. et al. Chronic kidney disease and the global public health agenda: an international consensus. Nat Rev Nephrol 20, 473–485 (2024). https://doi.org/10.1038/s41581-024-00820-6
[5] N Tangri et al.: Impact of Improved Diagnosis and Treatment on Holistic CKD Burden. https://doi.org/10.1016/j.ekir.2025.05.039
[6] Francis, A., Harhay, M.N., Ong, A.C.M. et al. Chronic kidney disease and the global public health agenda: an international consensus. Nat Rev Nephrol 20, 473–485 (2024). https://doi.org/10.1038/s41581-024-00820-6
[7] N Tangri et al.: Impact of Improved Diagnosis and Treatment on Holistic CKD Burden. https://doi.org/10.1016/j.ekir.2025.05.039

 

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Attachment

• Media Release CE Mark for AI-based Kidney Klinrisk Algorithm English

FAQ

What did Roche (RHHBY) announce on October 6, 2025 about the Kidney Klinrisk Algorithm?

The PR states Roche received a CE mark on 6 Oct 2025 for the AI‑based Kidney Klinrisk Algorithm and is launching it in a CKD algorithm panel.

How does Roche say the CKD algorithm panel (RHHBY) supports clinicians?

According to the company, the panel combines routine blood and urine inputs, aligns with clinical guidelines, and integrates via navify to help assess risk across CKD stages.

Where will Roche make the Kidney Klinrisk Algorithm available first (RHHBY)?

The PR states the panel is available in Europe and the United Kingdom at launch, with later availability planned for the United States, Middle East, and Asia.

What is the difference between the Kidney Klinrisk Algorithm and Kidney KFRE in Roche's announcement?

The PR describes Kidney Klinrisk as an AI‑based early risk assessment tool, while Kidney KFRE is the established CE‑marked algorithm for managing later CKD stages.

Will Roche (RHHBY) provide clinical accuracy or outcome numbers for the Kidney Klinrisk Algorithm in the PR?

The PR does not disclose clinical performance metrics or numeric validation results for the Kidney Klinrisk Algorithm.

On which Roche platform will the CKD algorithm panel be offered (RHHBY)?

Roche says the CKD panel will be offered via the cloud‑based navify Algorithm Suite, which integrates with hospital systems.