Kidney health is intricately connected with cardiovascular and metabolic health, and there is greater risk for cardiovascular events among patients with type 2 diabetes and impaired kidney function.
Significant for patients with early stage CKD, there are now several therapies with multiple beneficial effects on metabolic risk factors, kidney function, and the cardiovascular system, including ACEs, ARBs, SGLT2 inhibitors, GLP1 receptor agonists, and non-steroidal mineralocorticoid antagonists, enabling clinicians to leverage risk-based strategies to optimize metabolic, kidney and cardiovascular health.
That’s why it’s critical to predict kidney function decline accurately and reliably in the type 2 diabetes population as early as possible.
And that’s where kidneyintelX.dkd™ comes into play.
1 in 4 DKD patients are at increased risk for kidney failure and may benefit from more frequent monitoring, lifestyle changes, and treatment interventions. But which ones are they? Our kidneyintelX.dkd test can provide the answer.
Make decisions, more confidently.
The kidneyintelX.dkd risk result (Low, Moderate, High) can help you determine the appropriate level of care for your diabetic kidney disease (DKD) patients, including whether ongoing monitoring is needed or whether immediate therapeutic and lifestyle changes or multidisciplinary consultations or referrals to a specialist are warranted.
In multiple studies, we’ve demonstrated clinical performance for reliable risk stratification for DKD progression.
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Low Risk Level
Moderate Risk Level
High Risk Level
How does it work?
The kidneyintelX.dkd test combines well-established, prognostic, blood-based biomarkers with select clinical variables and applies a machine learning derived algorithm to identify those adult patients with type 2 diabetes and chronic kidney disease (stages 1-3b) who are at increased risk of progressive decline in kidney function (i.e., decrease in eGFR that is > 40%). And because the test identifies level (Low, Moderate, High) of risk early, it has the greatest chance of driving actions that mitigate disease progression and improve health outcomes overall.
The test has been clinically validated to accurately assess the risk of progressive decline in kidney function.
Here are some facts from the Study:
- Patients identified with a “low” result experienced kidney function decline comparable to that of normal aging (in the absence of diabetes or CKD), and zero patients reached end-stage kidney disease within 5 years.
- Patients identified with a “moderate” result experienced kidney function decline at a ratio of 4x greater than those identified with a “low” result.
- Patients identified with a “high” result experienced kidney function decline at a ratio of 18x greater than those identified with a “low” result.
For detailed performance characteristics of kidneyintelX.dkd, see our Product Technical Sheet here.
To read the Study and find information about the rate of decline seen for the different levels of risk, click here.
Of note, kidneyintelX.dkd has been recognized as the first and only FDA authorized test to enable risk assessment for progressive kidney function decline in adult patients with type 2 diabetes and chronic kidney disease (stages 1-3b). Therefore, kidneyintelX.dkd sets a high bar as the predicate for same or like tests reviewed by the FDA in the future.
1
Proprietary biomarkers
Biological factors that are clinically proven – in multiple studies – to be most prognostic for kidney disease progression (TNFR-1, TNFR-2, KIM-1).
2
Select clinical features
3 select clinical variables from a patient’s health record (UACR, HbA1c, BUN) which are indicative of kidney/other key organ health or dysfunction.
3
Validated algorithm
We use machine learning to optimize the value of these diverse and proprietary data inputs to report a patient-specific risk result.
4
Yields:
Clear and actionable test result that can help clinicians make medical decisions for today and tomorrow.
It’s a
win-win-win.
Patients
Empowered to participate fully in improving their own kidney care, and overall health.
Clinicians
Central to coordinating multi-disciplinary care, clinicians can advance kidney and cardiovascular health with more targeted focus for adult patients with type 2 diabetes and chronic kidney disease stages 1-3b.
Receive a simple result showing each patient's risk Level (Low, Moderate, High) for progressive decline in kidney function.
Can be even more confident in their decision-making to determine which patients will benefit most from recommended therapies outlined by the ADA, AAFP, and KDIGO guidelines, and/or consultation with a specialist.
Payers
By conducting a comprehensive risk assessment in stages 1-3b, and implementing associated precision care plans, can realize significant savings in both the earlier stages (which accounts for 70%1 of the cost of the disease) and preventing the escalating costs associated with multiple co-morbidities related to kidney, heart, and metabolic disease, including those which occur in the later stages of CKD (4-5).
Optimize risk sharing in value-based care environments.
The kidneyintelX.dkd test is implemented in stages 1-3b, the right time to have the most impact.
By starting in stages 1-3b of diagnosed kidney disease and implementing kidneyintelX.dkd – a test demonstrated to determine which adult patients with type 2 diabetes and chronic kidney disease stages 1-3b are at higher to lower risk for progressive decline in kidney function - clinicians and patients can reap the greatest benefits from the rest of the treatment plan.
Prognosis, not diagnosis.
Current kidney function measurements can diagnose the presence of kidney disease at a single point in time. Our kidneyIntelX.dkd is designed to predict whether an adult patient with type 2 diabetes and with chronic kidney disease stages 1-3b will progress over the next five years.
In fact, our KidneyIntelX test platform, has a growing body of evidence via validation, clinical outcomes and utility, and health economic studies, including an approximate 8-fold independent gradient of risk (even after adjustment) for standard risk factors for progression (age, sex, race, eGFR, UACR, HbA1c and blood pressure).
Why is it a win-win-win?
What do you mean by the right starting point?
Why prognosis vs diagnosis?
Why focus first on patients with type 2 diabetes?
We’re continuously solving problems.
Our research pipeline is full.
We are exclusively focused on chronic kidney disease and its co-morbidities for application of our test platform.
Today, kidneyintelX.dkd is a prognostic* test that predicts which type 2 adult diabetes patients with chronic kidney disease are at High, Moderate, or Low risk for progressive decline in kidney function.
We are also conducting research to expand our KidneyIntelX test platform to include next generation prognostic tools, and monitoring tools for efficacy and prediction of response to existing and novel therapeutics.
* kidneyintelX.dkd is not intended for screening or as a stand-alone diagnostic test.
