An ever-growing body of evidence.
Clinical Validation
Clinical Utility
After KidneyIntelX testing, there was a significant increase in visit frequency, referrals for disease management, and introduction to guideline-recommended medications.
Patients scored high-risk by KidneyIntelX derived 3X greater magnitude in the protective effect of canagliflozin on kidney function decline
Economic Utility

KidneyIntelX risk assessment can yield 5-year cost savings of $1.1 billion for every 100,000 patients with T2D and CKD
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Validation of Proprietary Bioprognostic Methodology
Budget Impact Analysis
Therapeutic Integration & Utility Studies
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Validation Studies of Bioprognostic Methodology
1. Initial Validation Study, Predicting Longitudinal Kidney Outcomes
Who: Type 2 diabetes patients and APOL1 high risk genotype who are at higher risk for rapid kidney disease progression and failure in five years
What: Prognostic test integrating blood biomarkers, longitudinal electronic health record data and machine learning to improve risk stratification
Where: Published in the global, peer-reviewed, kidney journal, Kidney360
Protocol: Approved by review boards at Mount Sinai that also provided biobank samples and EHR data. Clinical validation of the customized patient test score was provided by an independent biostatistician.
Results:
KidneyIntelX test platform demonstrated successful risk stratification at both ends of the spectrum in two high risk populations
- Low-risk assessments were highly-reliable: 92% of patients who received a ”low risk score” did not progress in their kidney disease
- High-risk assessments were also highly-reliable: 62% of patients who received a “high risk score” experienced significant progression in their kidney disease
- A second population of at-risk patients (African American descent with underlying APOL1 high risk genotype) were tested with KidneyIntelX, yielding very similar findings, 96% and 62%, respectively
2. Derivation and validation of a risk score to predict progression of diabetic kidney disease
Who: 1,146 type 2 diabetes patients (median age 63, 51% female) selected from the BioMe Biobank at the Icahn School of Medicine and the Penn Medicine Biobank (PMBB) databases, 21-81 years old, KDIGO stage G3a-G3b with all grades of albuminuria (A1-A3) and stage G1-G2 with moderate to high albuminuria (UACR > 30 mg/g (A2-A3)).
What: Develop and validate the performance of a new biomarker-enriched, machine learning risk score to predict rapid progressive decline in kidney function in patients with early-stage DKD and compare the performance with standard clinical models.
Where: Published in Diabetologia, a monthly, peer-reviewed medical journal covering diabetology. It is also the official journal of the European Association for the Study of Diabetes.
Protocol: An observational cohort study of patients with prevalent DKD/banked plasma from two EHR-linked biobanks. A random forest model was trained, and performance was compared with that of a multivariable clinical model for kidney disease progression, as well as KDIGO risk strata.
Results: Substantiating study proved that KidneyIntelX improved prediction of kidney outcomes over KDIGO and clinical models in individuals with early stages of DKD.
- Using derivative cut-offs, KidneyIntelX stratified 46%, 37% and 17% of the validation cohort into low-, intermediate, and high-risk groups for the composite kidney endpoint, respectively.
- In those with the standard of care UACR value available (62% of the validation cohort), the positive predictive value for progressive decline in kidney function in the high-risk group was 69% for KidneyIntelX vs 40% for the highest risk strata by KDIGO categorization (72% relative improvement).
- Only 7% of those scored as low risk by KidneyIntelX and UACR experienced progression (negative predictive value of low risk was 93%).
3. Clinical Utility of KidneyIntelX with Early Stages of Diabetic Kidney Disease (DKD)
Who: 1,325 type 2 diabetes patients with DKD from 24 countries
What: Study goals were to (1) demonstrate that baseline KidneyIntelX assessment provides reliable risk stratification for kidney outcomes in a multi-national population; (2) to assess the impact of canagliflozin versus placebo in patients within risk strata of KidneyIntelX risk; (3) to assess the impact of SGLT2i treatment on changes in longitudinal KidneyIntelX risk scores over time; and (4) to determine the added value of early longitudinal changes in KidneyIntelX for forecasting subsequent kidney outcomes (i.e., progressive DKD).
Where: Published in the American Journal of Nephrology, a peer-reviewed journal that focuses on timely topics in both basic science and clinical research.
Protocol: Multicenter, double-blinded, placebo-controlled, randomized trials (CANVAS and CANVAS-R) done to assess the effect of canagliflozin on primarily cardiovascular events, kidney function, and safety outcomes. Participants assigned to treatment with canagliflozin or placebo were followed for a median of 6.1 years.
Results: KidneyIntelX successfully risk stratified a large multinational external cohort for progression of DKD
- The risk for progression of diabetic kidney disease for those scored as high-risk on KidneyIntelX was 8-fold greater vs those that scored as low risk.
- Individuals with higher baseline KidneyIntelX risk scores derived greater numerical differences in long-term eGFR slope with treatment with canagliflozin versus placebo (0.66, 1.52, and 2.16 mL/min/1.73m2 in the low, intermediate, and high KidneyIntelX risk strata, respectively).
- Canagliflozin treatment reduced KidneyIntelX risk scores over time, and changes in the KidneyIntelX score from baseline to 1 year associated with future risk of DKD progression, independent of baseline risk score and treatment arm.
https://doi.org/10.1080/13696998.2021.1960714
1. Real-World Evidence and Clinical Utility of KidneyIntelX on Patients with Early-Stage DKD
Who: The study was conducted in collaboration with the Mount Sinai Health System’s Population Health Ambulatory Pharmacy and Condition Management programs and included 1,686 patients seen by 75 providers at 20 clinical sites. The majority of patients were being treated by their primary care doctor.What: Will integrating an easily interpretable, accurate prognostic tool (KidneyIntelX) that assigns a risk score for progressive decline in kidney function, enable providers to act earlier to slow or stop the progression to kidney failure? Will the KidneyIntelX test result in changed clinical decision making for patients in the early stages of DKD?
(Note: Prediction of risk for kidney disease progression in early-stage DKD is often not assessed at the primary care level, resulting in more than 50,000 individuals per year with diabetes progressing to kidney failure, dialysis or a kidney transplant.)
Where: Published in Primary Care and Community Health, a peer-reviewed, open access journal which focuses on the study, practice, impact and outcomes of primary care services and community health programs.
Protocol: KidneyIntelX was introduced into a large metropolitan Health System via a population health-defined approved care pathway for patients with stages 1 to 3 DKD between November 2020 to March 2022. Decision impact on visit frequency, medication management, specialist referral, and selected lab values was assessed. We performed an interim analysis in patients through 6-months post-test date to evaluate the impact of risk level with clinical decision-making and outcomes.
Results:
Increased follow-up and patient engagement.
- 71% of patients with high-risk scores had a clinical encounter within the first month. (vs. Standard of Care q12m)
Appropriate improvements in pharmacy management.
- 57% of high-risk patients had action taken (medication change or referral) within 3-months, compared to 35% for low-risk patients.
- Medication changes included introducing SGLT2 inhibitors to manage type 2 diabetes and CKD as well as adjustments for ACEi/ARBs to manage hypertension.
Improved control of Type 2 Diabetes.
- The study showed a 10% improvement in HbA1c levels in the first six months.
- This is most likely the result of increased patient engagement combined with appropriate medication changes including the introduction of SGLT2 inhibitors.
Improved control of chronic kidney disease.
- At the 6-month data mark, there was a 15% improvement in albuminuria, an important indicator of overall kidney health, in the low and intermediate risk groups (While other metrics such as eGFR and systolic blood pressure (SBP) remained unchanged)
2. Therapeutic Integration of KidneyIntelX with Early Stages of Diabetic Kidney Disease (DKD)
Who: 1,325 type 2 diabetes patients with DKD from 24 countriesWhat: Study goals were to (1) demonstrate that baseline KidneyIntelX assessment provides reliable risk stratification for kidney outcomes in a multi-national population; (2) to assess the impact of canagliflozin versus placebo in patients within risk strata of KidneyIntelX risk; (3) to assess the impact of SGLT2i treatment on changes in longitudinal KidneyIntelX risk scores over time; and (4) to determine the added value of early longitudinal changes in KidneyIntelX for forecasting subsequent kidney outcomes (i.e., progressive DKD).
Where: Published in the American Journal of Nephrology, a peer-reviewed journal that focuses on timely topics in both basic science and clinical research.
Protocol: Multicenter, double-blinded, placebo-controlled, randomized trials (CANVAS and CANVAS-R) done to assess the effect of canagliflozin on primarily cardiovascular events, kidney function, and safety outcomes. Participants assigned to treatment with canagliflozin or placebo were followed for a median of 6.1 years.
Results: KidneyIntelX successfully risk stratified a large multinational external cohort for progression of DKD
- The risk for progression of diabetic kidney disease for those scored as high-risk on KidneyIntelX was 8-fold greater vs those that scored as low risk
- Individuals with higher baseline KidneyIntelX risk scores derived greater numerical differences in long-term eGFR slope with treatment with canagliflozin versus placebo (0.66, 1.52, and 2.16 mL/min/1.73m2 in the low, intermediate, and high KidneyIntelX risk strata, respectively).
- Canagliflozin treatment reduced KidneyIntelX risk scores over time, and changes in the KidneyIntelX score from baseline to 1 year associated with future risk of DKD progression, independent of baseline risk score and treatment arm
3. Clinical utility and clinical implementation of the KidneyIntelX prognostic tool
What: Demonstrate the decision-making impact (demand for test, adoption and clinical utility) of the risk-assessment, prognostic tool, KidneyIntelX, in the management of DKD among primary care physicians (PCPs).
Where: Published in the American Journal of Managed Care.
Protocol: There was a prospective web-based survey administered among PCPs across the United States. Conjoint analysis with multivariable logit models were used to estimate PCP preferences. The survey included hypothetical patient profiles with 6 attributes” albuminuria, eGFR, age, blood pressure, glycated hemoglobin A1c (HbA1c) and KidneyIntelX result. Each PCP viewed 8 patient profiles randomly selected from 42 unique profiles having 1 level from each attribute.
For each patient, PCPs were asked to indicate whether they would prescribe a sodium-glucose cotransporter-2 (SGLT2) inhibitor, increase angiotensin receptor blocker (ARB) dose and/or refer to a nephrologist.
Specific Results:
There was unprecedented behavior change demonstrated among PCPs: adoption, clinical utility and clinical application. The KidneyIntelX test had greater relative importance than albuminuria and eGFR to PCPs in making treatment decisions and was second only to eGFR for referring to nephrologists.
- A total of 401 PCPs completed the survey, with a response rate of 8.8%.
- The relative importance of the top 2 attributes for each decision were HBA1c (52%) and KidneyIntelX result ( 23%) for prescribing SGLT2 inhibitors; BP (62%) and KidneyIntelX results (13%) for increasing ARB dose and eGFR (42%) and KidneyIntelX result (27%) for nephrologist referral.
- A high-risk KidneyIntelX result was associated with higher odds of PCPs prescribing SGLT2 inhibitors , increasing ARB dose and referring to a nephrologist
Big Takeaways:
- Demonstrated PCP demand makes the case for increasing patient access to this innovative prognostic tool
- Demonstrated that KidneyIntelX satisfies an unmet need in standard-of-care management for DKD, indicating a need for change in practice guidelines
- This Study complements data from a real-world evidence clinical utility study of 1112 adult DKD patients presented at the ADA 82nd Scientific Sessions and the European Congress of Internal Medicine. These combined results confirm the significant benefit of using KidneyIntelX in the Primary Care setting to direct care towards improving kidney health and reducing the significant financial burden associated with DKD.
50,000 DIABETIC PATIENTS/YEAR PROGRESS TO KIDNEY FAILURE.
Our simple blood test can help you identify which of your patients are at the highest risk.