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Back to directoryRoche Kidney Klinrisk Algorithm medical AI product profile
AI-powered CKD progression risk algorithm that uses standard demographic and lab parameters to produce kidney-function decline risk scores and clinical decision support.
Precision medicine and data
Best fit
European or UK care pathways that need integrated CKD risk stratification for adults with CKD stages G1-G4 or adults with diabetes or hypertension at risk for CKD.
- Primary use case
- CE-marked AI-powered machine-learning algorithm for CKD progression risk stratification through the navify Algorithm Suite
- Audience
- Laboratories, nephrology groups, primary care networks, endocrinology teams, population health programs, and hospitals evaluating CKD risk stratification
- Risk level
- High
- Pricing signal
- Roche commercial pricing is not public; verify current country availability, algorithm-suite access, lab integration, support, and contract terms.
- Official sources
- 5 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Roche Kidney Klinrisk Algorithm as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as regulated IVD software and verify CE/IVDR status, region, outpatient use, intended population, non-diagnostic boundaries, algorithm version, and whether local deployment needs additional medical-device governance. |
|---|---|
| Privacy | Review navify Algorithm Suite hosting, LIS/EMR integration, lab-result data flow, role access, audit logs, retention, cloud region, processor terms, and cross-border transfer controls. |
| Evidence | Check validation cohorts, performance metrics, CKD stages, diabetes and hypertension subgroups, eGFR and ACR input quality, external validation, and local calibration before relying on risk tiers. |
| Workflow | Best governed as clinician-reviewed CKD risk stratification that supports monitoring frequency, treatment review, and referral planning while keeping patient-management decisions with qualified professionals. |
Where Roche Kidney Klinrisk Algorithm fits
Roche and KlinRisk materials describe Kidney Klinrisk Algorithm as an AI-powered, locked machine-learning in vitro diagnostic device for estimating CKD progression risk over up to five years; Roche says it received CE marking and is delivered through navify Algorithm Suite, while KlinRisk publishes product and validation materials for the CKD progression model.
Not for: Primary diagnosis, screening as a standalone disease test, unsupervised patient management, or use outside the certified region, outpatient setting, inputs, and intended-use population.
What to verify before using Roche Kidney Klinrisk Algorithm
- Whether Kidney Klinrisk Algorithm is available and certified for the deployment country, patient group, outpatient setting, and navify Algorithm Suite configuration.
- Which inputs are required, how they are sourced from LIS, EMR, or laboratory workflows, and how missing or stale data is handled.
- Cloud architecture, data transfer, role access, audit logging, retention, hospital integration, processor terms, and Roche or partner support access.
- Validation evidence, risk-category calibration, guideline alignment, clinician review, nephrology referral thresholds, and post-launch performance monitoring.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- navify.roche.com / marketplace / products
- navify.roche.com / gb / en-gb
- www.roche.com / media / releases
- www.klinrisk.com / ckd
- www.klinrisk.com / thescience
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