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Back to directoryKidneyIntelX.dkd medical AI product profile
AI-enabled in vitro diagnostic test that combines biomarkers and clinical variables to stratify kidney disease progression risk.
Precision medicine and data
Best fit
Care teams that need a regulated kidney-risk stratification workflow with lab operations, clinician review, and treatment-planning follow-through.
- Primary use case
- FDA-authorized AI-enabled prognostic blood test for assessing risk of progressive kidney function decline in diabetic kidney disease
- Audience
- Nephrology, primary care, endocrinology, population health, laboratory, and value-based care teams managing adults with type 2 diabetes and chronic kidney disease
- Risk level
- High
- Pricing signal
- Renalytix investor materials say Medicare priced kidneyintelX.dkd at $950 per reportable result; verify current payer, contract, and ordering 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 KidneyIntelX.dkd as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a regulated in vitro diagnostic and match deployment to the FDA De Novo intended use, ordering requirements, lab status, and any local diagnostic governance before clinical use. |
|---|---|
| Privacy | Review specimen handling, LIMS data flows, EHR integration, laboratory access, ISO/IEC 27001 scope, retention, payer data exchange, and BAA or covered-entity terms. |
| Evidence | Check FDA decision materials, validation population, biomarker and clinical-variable inputs, real-world performance, reimbursement evidence, and local outcome tracking before scaling. |
| Workflow | Best governed as a clinician-reviewed kidney-risk pathway where results trigger documented follow-up, medication or referral review, patient counseling, and post-deployment monitoring. |
Where KidneyIntelX.dkd fits
Renalytix and KidneyIntelX materials describe kidneyintelX.dkd as an AI-enabled prognostic blood test for diabetic kidney disease; FDA De Novo DEN200052 lists KidneyIntelX.dkd with a June 29, 2023 decision date, and company security materials describe CLIA laboratory operations and ISO/IEC 27001 certification.
Not for: General kidney screening, autonomous diagnosis, therapy selection without clinician review, or use outside the FDA-authorized intended population and local lab ordering workflow.
What to verify before using KidneyIntelX.dkd
- Whether the patient population matches the FDA-authorized intended use for adults with type 2 diabetes and early-stage chronic kidney disease.
- How the blood test, clinical variables, ordering workflow, result delivery, and follow-up actions fit existing nephrology or primary care pathways.
- Current lab certification, data-security posture, payer coverage, Medicare reimbursement, and patient financial responsibility.
- How clinicians validate risk tiers, document treatment changes, monitor outcomes, and avoid over-reliance on a prognostic score.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.kidneyintelx.com
- www.kidneyintelx.com / clinicians-faqs
- www.kidneyintelx.com / data-security
- www.accessdata.fda.gov / cdrh_docs / reviews
- investors.renalytix.com / news-release / medicare-prices-kidneyintelx-dkd-at-950
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