KidneyIntelX.dkd
by Renalytix AI
· Based in United Kingdom →
— The proven prognostic solution to improve kidney health. It's bioprognosis.
Paid
Regulatory Status Disclosed
Overview
KidneyIntelX.dkd is an FDA-authorized, AI-enabled in-vitro diagnostic solution developed by Renalytix AI. It is designed to assess the risk of progressive decline in kidney function in adult patients with Type 2 diabetes and existing chronic kidney disease (stages 1-3b). The test combines measurements of three proprietary plasma biomarkers (TNFR-1, TNFR-2, and KIM-1) with clinical features from electronic health records (such as UACR, HbA1c, and BUN). An AI-enabled algorithm then processes these diverse data inputs to generate a personalized risk score (Low, Moderate, or High), providing actionable insights to clinicians for early intervention and personalized care planning. The test is performed exclusively at Renalytix’s CLIA-certified clinical laboratory.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-enabled algorithm combining biomarkers and clinical data
- Measures plasma TNFR-1, TNFR-2, and KIM-1 biomarkers
- Integrates clinical features from EHRs (UACR, HbA1c, BUN, eGFR)
- Generates a personalized risk score (Low, Moderate, High) for kidney function decline
- Prognostic use for early-stage Diabetic Kidney Disease (DKD)
- In-vitro diagnostic performed at CLIA-certified laboratory
- Integration with clinical workflows and Electronic Health Records (EHRs)
- Provides actionable test reports to ordering physicians
Use Cases
- Assessing risk of progressive decline in kidney function in adult patients with Type 2 diabetes and CKD (stages 1-3b)
- Guiding personalized treatment plans and care interventions for kidney disease
- Identifying patients who could benefit from additional examinations, increased monitoring, and lifestyle changes
- Improving clinical decision-making in primary care settings for DKD patients
- Patient stratification for drug clinical trials related to kidney disease
- Drug target discovery in kidney disease
What Physicians Need to Know
Key Capabilities
Predicts 5-year risk of progressive decline in kidney function in adults with type 2 diabetes and early-stage chronic kidney disease (stages 1-3b). Utilizes a bioprognosticu2122 methodology combining three proprietary blood-based biomarkers (TNFR1, TNFR2, KIM-1) with clinical data (UACR, HbA1c, BUN) via a machine learning algorithm to generate a patient-specific risk score (Low, Moderate, High).
Clinical Utility
Enables earlier, more targeted interventions such as optimization of guideline-recommended medications (e.g., SGLT2 inhibitors, GLP-1 receptor agonists, ACEi/ARB), increased specialist referrals, and improved patient engagement. Real-world evidence demonstrates improved glycemic control and albuminuria reduction, leading to better patient outcomes. It has shown superior prognostic accuracy compared to traditional methods like KFRE and KDIGO in early-stage DKD.
Integration Options
Designed for integration into existing clinical workflows, including electronic health records (EHR) to facilitate one-click ordering and data collection. Renalytix directly implements integrations with healthcare providers and is collaborating with Tempus AI for advanced EHR integration and data-driven solutions.
Compliance Status
FDA-authorized (De Novo marketing authorization) as the first and only prognostic test for progressive kidney function decline in adult patients with type 2 diabetes and CKD (stages 1-3b). It is Medicare reimbursed with a national payment rate. Renalytix has completed CE marking submissions for European commercialization, with completion anticipated in Q3 2026.
Pricing Model
The established Medicare reimbursement rate for KidneyIntelX.dkd is $950 per test. Economic analyses project substantial cost savings for payers, primarily due to slowed disease progression, delayed or prevented dialysis, and reduced transplant costs, with a breakeven point expected within two years of adoption.
User Experience
The test involves a simple, non-fasting blood draw. The results are presented in an easy-to-understand risk report (Low, Moderate, High), providing clear guidance for clinical decision-making and enabling primary care physicians to confidently assess patient risk and determine appropriate care plans.
Support Quality
Renalytix provides educational resources and practical support for clinicians. A Clinical Advisory Board, composed of world-leading, multi-disciplinary experts, has been formed to support the broader adoption and effective use of KidneyIntelX.dkd.
Implementation Complexity
Described as 'simple to implement' within existing office workflows. Integrations with healthcare provider systems are directly managed by Renalytix. It requires the collection of a blood sample and specific clinical data (UACR, HbA1c, BUN) for the test.
Evidence Base
Supported by extensive clinical validation studies, real-world evidence (RWE) studies (e.g., Mount Sinai Health System), and numerous peer-reviewed publications. Studies demonstrate significant improvement in predicting progressive kidney function decline and influencing clinical management compared to standard of care.
Physician Tip
KidneyIntelX.dkd offers a critical tool for early risk stratification in type 2 diabetes patients with early-stage CKD, enabling proactive and personalized management. Utilize the clear risk scores (Low, Moderate, High) to guide timely interventions, including optimizing renoprotective medications (SGLT2i, GLP-1 RA), increasing follow-up frequency, and making appropriate specialist referrals. This can significantly slow disease progression and improve patient outcomes, particularly in primary care settings where early identification is crucial.
The tool is designed for seamless integration into existing electronic health record (EHR) systems, allowing for efficient one-click ordering and streamlined data flow. Renalytix actively supports and directly implements these integrations with healthcare providers. Ongoing collaborations, such as with Tempus AI, aim to further enhance EHR connectivity and leverage data for future kidney disease solutions, facilitating a more integrated approach to patient care.
Details
| Category | Endocrinology & Metabolic AI, Lab & Diagnostics |
| Pricing |
Paid
|
| Deployment | Laboratory-based (test performed at Renalytix's clinical laboratory) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated KidneyIntelX.dkd received FDA De Novo Marketing Authorization on June 29, 2023, as the first and only FDA-authorized prognostic test for early-stage Chronic Kidney Disease (CKD) risk assessment in adult patients with Type 2 diabetes (T2D) and existing CKD (stages 1-3b). |
| Integrations | |
| EHR | Not specified |
| Specialties | Endocrinology, Internal Medicine, Nephrology |
What the Web Says
KidneyIntelX.dkd is an FDA-authorized AI-enabled prognostic test designed to assess the risk of progressive kidney function decline in adults with type 2 diabetes and early-stage chronic kidney disease (stages 1-3b). It combines three blood-based biomarkers with clinical data from electronic health records to generate a personalized risk score. Physicians and studies indicate that the test helps in earlier identification of high-risk patients, leading to improved clinical decision-making, more targeted interventions, and better patient outcomes, including increased use of guideline-recommended medications and specialist referrals.
Overall: PositiveStrengths
- Improved risk stratification for progressive kidney function decline compared to standard care.
- Enables earlier and more targeted clinical interventions, such as increased prescriptions for SGLT2 inhibitors and specialist referrals.
- Associated with improved clinical outcomes, including reduced eGFR decline, improved HbA1c levels, and decreased albuminuria.
- Supported by real-world evidence studies demonstrating its effectiveness in diverse patient cohorts.
- First and only FDA-authorized test for risk assessment of progressive kidney function decline in this patient population.
- Cost-effective, with potential for significant healthcare cost savings.
Limitations
- Relatively new technology, and its long-term acceptance and utility in broader clinical practice are still evolving.
- Not intended as a screening or stand-alone diagnostic test, requiring interpretation in conjunction with other clinical findings.
- Disease progression can still occur in patients categorized as low risk, and not all high-risk patients will experience progression.
- Some forward-looking statements from the company acknowledge uncertainties regarding widespread adoption and expanded insurance coverage.
Based on reviews from: Mount Sinai, Renalytix, PubMed, Morningstar, PR Newswire, Reddit, accessdata.fda.gov
Last updated: 2026-07-18
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Press & Coverage
Renalytix Investors
Key milestones achieved for kidneyintelX.dkd
Renalytix announced key regulatory milestones for KidneyIntelX.dkd, including FDA approval, Medicare reimbursement, and the successful transfer of laboratory operations to a new facility in New York, increasing testing capacity by over 3.5x. The company also completed the submission for CE marking of KidneyIntelX.dkd, with finalization expected in Q3 2026.
2026-04
Renalytix Press Releases
KidneyIntelXu00ae Delivers Unprecedented Two-Year Real-World Outcomes in Diabetic Kidney Disease: No Comparable Risk Assessment Tool Exists
Renalytix announced results from a two-year real-world evidence study for its FDA-approved KidneyIntelX.dkd test, published in Diabetes, Obesity and Metabolism. The study, involving 2,470 patients, demonstrated sustained improvements in kidney function, treatment uptake, and patient risk levels.
2026-06
PR Newswire
Renalytixu2122 and Carna Health Partner to Solve Kidney Disease Crisis: Bridging the Existing Gap Between Population Screening and Precision Intervention
Renalytix and Carna Health announced a partnership to address the kidney disease crisis by integrating Renalytix's FDA-approved KidneyIntelX.dkd test with Carna Health's AI-driven prevention and digital care management platform. This collaboration aims to enable risk-guided, personalized care pathways for patients with type 2 diabetes and early-stage CKD.
2026-05
PR Newswire
Pivotal kidneyintelX.dkd Data Published in Diabetes Care, Considered the Leading Clinical Journal Worldwide in Diabetes
Renalytix announced the publication of pivotal new data for KidneyIntelX.dkd in Diabetes Care, the top-ranked global diabetes journal. The study demonstrated that KidneyIntelX.dkd significantly enhanced risk stratification for CKD progression and potential kidney failure, and provided actionable treatment guidance.
2025-11
Renalytix Investors
First use of KidneyIntelX in new CKD therapy trial
Renalytix announced the first use of KidneyIntelX in a clinical trial for a novel cell therapy for Chronic Kidney Disease, marking a key milestone in diversifying revenue streams and supporting pharmaceutical companies with precision medicine solutions. KidneyIntelX.dkd is the only FDA-approved and Medicare-reimbursed prognostic test for early-stage risk assessment in CKD.
2025-05
Renalytix Investors
Late Breaking KidneyIntelX data show care impact
Renalytix highlighted new data demonstrating the impact of KidneyIntelX on targeted use of SGLT2 inhibitors in patients with diabetic kidney disease. The study showed that KidneyIntelX testing led to increased and targeted SGLT2i prescriptions, particularly for moderate and high-risk patients.
2025-04
Renalytix
KidneyIntelXu2122 included in Final KDIGO 2024 Clinical Guideline for Chronic Kidney Disease (CKD)
Renalytix announced that the KidneyIntelX In-Vitro Diagnostic test has been included in the final KDIGO (Kidney Disease Improving Global Outcomes) 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. This inclusion underscores the importance of risk prediction in guiding early intervention for CKD patients.
2024-03
FDA.gov
FDA Grants De Novo Marketing Authorization for KidneyIntelX.dkd to Assess Risk of Progressive Kidney Function Decline in Adults with Diabetes and Early-Stage Kidney Disease
The FDA granted De Novo marketing authorization for KidneyIntelX.dkd on June 29, 2023. This classification allows the device to be marketed as a prognostic test to aid in assessing the risk of progressive decline in kidney function in adults with type 2 diabetes and existing chronic kidney disease.
2023-06
Videos
Product demos, reviews, and walkthroughs for KidneyIntelX.dkd.
MSBI DOM Grand Rounds
Frequently Asked Questions
KidneyIntelX.dkd is an AI-enabled prognostic test that combines blood biomarkers and clinical data to stratify adult patients with type 2 diabetes and early-stage chronic kidney disease (CKD stages 1-3b) into low, moderate, or high risk for progressive kidney function decline within five years. This risk assessment aids physicians in optimizing care plans, including targeted therapeutic interventions and specialist referrals, to potentially slow disease progression.
KidneyIntelX.dkd received De Novo marketing authorization from the U.S. FDA in June 2023, establishing it as a first-in-class prognostic test for assessing chronic kidney disease progression. This authorization affirms its rigorous safety, clinical, and analytical validation.
KidneyIntelX.dkd is not intended for screening, stand-alone diagnosis, or staging of diabetic kidney disease, nor is it for use in non-diabetic patients. It is specifically indicated for adult patients aged 21 and older with type 2 diabetes and existing chronic kidney disease (eGFR 30-59 ml/min/1.73 mu00b2 or eGFR u2265 60 ml/min/1.73 mu00b2 with albuminuria (UACR u2265 30 mg/g)).
Unlike traditional measures such as eGFR and UACR alone, KidneyIntelX.dkd utilizes a proprietary algorithm combining three blood-based biomarkers with clinical data to provide a more precise, individualized 5-year risk assessment for progressive kidney function decline. It is currently the only FDA-authorized test specifically for this prognostic purpose.
The established Medicare price for KidneyIntelX.dkd is $950 per test, effective August 1, 2024, with distinct CPT codes. It also has coverage through various commercial insurance programs and provider agreements with over 30 state Medicaid programs.
Renalytix states that all KidneyIntelX.dkd tests are processed through its clinical laboratories, which are CLIA-certified, ISO-certified, CAP-accredited, and FDA-compliant. These certifications imply adherence to stringent data handling and security standards for patient information.
The KidneyIntelX.dkd test results are intended to be used as an aid in assessment and should always be interpreted in conjunction with the patient's complete medical history, clinical presentation, physician assessment, and other diagnostic findings. It is not a stand-alone diagnostic tool, emphasizing the continued importance of clinical judgment.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19