Now, you can

more fully understand risk.
more fully understand risk.

Reliably, simply, efficiently.

All types of kidney disease are not equal. Until now, one big question has been: which patients with kidney disease are at higher vs lower risk for rapid progression to kidney failure?

With KidneyIntelXTM, you will get more answers to help you make decisions about patient management.

KidneyIntelX has been demonstrated to be a highly-reliable, bioprognosticTM that yields a simple-to-understand, custom risk score, identifying adult patients with type 2 diabetes and chronic kidney disease stages 1-3b, who are at low, intermediate or high risk for rapid progressive decline in kidney function.

Make decisions, more confidently.

With KidneyIntelX, you can identify which patients need lower-level maintenance or ongoing monitoring or immediate lifestyle and therapeutic changes and referrals to a specialist.

In multiple studies, we’ve demonstrated clinical validation for reliable risk stratification. KidneyIntelX “categorized” patients into three risk tiers: low, intermediate and high. In addition to the patient risk score, each report comes complete with actionable, guideline-recommended care pathways.

Low Risk Result

(5 to 45)

Approximately 50% of patients tested with KidneyIntelX are expected to receive a low-risk score. A low-risk score (“green”) means that your adult patient with type 2 diabetes and chronic kidney disease stages 1-3b, is at the lowest risk for progressive decline in kidney function. Clinical studies have shown that the risk that an individual with this score will experience such a decline over the next five years is < 10%.

Intermediate Risk Result

(50 to 85)

Approximately 35% of all patients tested with KidneyIntelX are expected to receive an intermediate risk score. With an intermediate-risk score (“orange”), you may recommend that the patient monitors his/her kidney health more frequently, which may include additional visits, additional blood work, some lifestyle changes and potentially, the introduction of specialized medication.

High Risk Result

(90 to 100)

Approximately 15% of patients tested with KidneyIntelX are expected to receive a high-risk score, which means that they have a 60% or higher chance of experiencing progressive decline in kidney function over the next five years. With a high-risk score, you may act more quickly and aggressively in the treatment of your patients’ kidney disease, which could include more frequent follow-up visits, referrals to a nephrologist, maximizing current medications and/or introducing new medications.

KidneyIntelXTM.

It’s not just analytics. It’s BioprognosisTM.

How does it work?
Our 3-part, proprietary methodology – bioprognosisTM for kidney health – provides risk assessment for rapid progressive decline in kidney function in stages 1-3b, when it has the best chance for improving outcomes and promoting overall patient health.

1

Proprietary biomarkers

Biological factors that are clinically proven – in multiple studies – to be most prognostic for kidney disease (TNFR1, TNFR2, KIM-1).

Read Biomarker Clinical Study here

2

Select clinical features

7 select data points from a patient’s health record (eGFR, UACR, serum calcium, HbA1c, systolic BP, platelets, AST) that are indicative of kidney/other key organ health or dysfunction.

3

Validated algorithm

We use machine learning to combine these diverse and proprietary data inputs to maximize their value through a patient-specific risk score.

4

Yields:

Clear and actionable test report: we provide both the risk score and a guideline-recommended clinical pathway to help doctors make medical decisions today and tomorrow.

It’s a
win-win-win.

Patients

Empowered to participate fully in their own kidney- and overall health care through actionable knowledge.

Doctors

Can advance kidney health with more pointed focus on adult patients with type 2 diabetes and chronic kidney disease stages 1-3b.

Can gain confidence for decision-making by knowing each patient’s relative risk (low to high) for rapid progressive decline in kidney function.

Receive a simple and actionable risk score to help determine which patients will benefit most from guideline-recommended therapies and consultation with a specialist.

Payers

By conducting 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% of the cost of the disease) and in the later stages (4-5).

Optimize risk sharing in value-based care environments.

KidneyIntelX begins at the right starting point. Not too early, nor too late.

Where is KidneyIntelX implemented? Stages 1-3b.

By starting in stages 1-3b of diagnosed kidney disease and implementing KidneyIntelX – a test demonstrated to predict which adult patients with type 2 diabetes and with chronic kidney disease stages 1-3b are at more or less risk for rapid 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. KidneyIntelX is designed to predict whether or not an adult patient with type 2 diabetes and which chronic kidney disease stages 1-3b will progress, possibly resulting in kidney failure.

In fact, KidneyIntelX has a growing body of evidence via validation, utility and economic studies, including a demonstrated 72% improvement in predicting those patients who are at high risk for rapid progressive decline in kidney function vs current standard of care.

1 in 3 adults with diabetes has kidney disease.
That’s why it’s our first area of focus.

The number of adults with diagnosed diabetes is expected to reach 60 million by 20601.

This fact is much more problematic as diabetes is the leading cause of chronic kidney disease, representing nearly 40% of its cases2. Further, in the U.S., the average incidence rate of dialysis has been 12x greater in persons with diabetes. By 2000, diabetic patients comprised 51% of the incident dialysis population.3

That’s why our first KidneyIntelX product indication for use is focused on diabetic kidney disease.

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 pipeline is full.

We are exclusively focused on chronic kidney disease and its co-morbidities as it relates to our ever-growing testing platform.

Today, KidneyIntelX is a test that predicts which type 2 adult diabetes patients with chronic kidney disease are at more or less risk for rapid progressive decline in kidney function.

In the future, we expect to have a test platform that includes screening, diagnosis, new prognostic tools, and prediction and monitoring of response to existing and novel new therapeutics.

Our portfolio of available and developmental laboratory-developed tests is backed by discovery and research with leading centers across the U.S. and internationally, including, Joslin Diabetes Center, Harvard University, University of Utah, and the University of Michigan.

Available Today

Pipeline

intelX.dkd

Reliably, simply, and more confidently identify the risk for rapid kidney disease progression among adult diabetic kidney disease patients. Enable precise and meaningful care across a base of patients, with greater resource and time allocation and guideline-recommended therapeutic options for those patients at higher risk.

intelX.community

Black American adults have a higher incidence of chronic kidney disease, partially due to genetic makeup. This test seeks to provide clinicians with the ability to reliably, simply and confidently identify those select, non-diabetic patients with this ancestry, who are at higher vs lower risk for kidney disease progression to treat accordingly.

intelX.vista

The test aims to provide doctors with valuable insights about their adult diabetic kidney disease patients garnered from a broader and longer-term view through ongoing monitoring, repeat testing, and the evaluation of different therapeutics.