CKD is expected to become an even

higher leading cause of death in the next two decades.

Chronic kidney disease (CKD) is a major global public health issue, affecting over 10%1 of the population worldwide. The problem was ranked 16th among the leading causes of death in 2016 and is expected to rise to 5th by 20402, making it a larger problem than heart disease or certain cancers.

Year: 2016 Estimated 2040:
Disease state Leading cause of death Leading cause of death
Chronic Kidney Disease #16 #5
Ischemic Heart Disease #17 #6
Lung Cancer #30 #15
Diabetes #45 #22

And CKD comes with a tremendous cost burden.

Chronic Kidney Disease (CKD): Just the Facts3

15% of U.S. Population

1 in 7 U.S. adults have CKD (without diabetes)

1 in 3 (33% of U.S. population with diabetes, the leading cause)

$70B+ Price Tag

U.S. adults (66+ years) with CKD represent 23.8% of Medicare spending

Double the Per-patient Spending

Annual per-person Medicare spending for patients 66+ with CKD ($23,691) compared with those without CKD ($10,842)

Actionable risk stratification in stages 1-3b is key to answering these challenges.

Health systems can proactively reduce the number of CKD patients who “fall off” the ledge and require dialysis or transplant.

KidneyIntelXTM, our laboratory-developed test (LDT), has been validated in two large cohorts to be a highly-reliable, bioprognosticTM methodology, that yields a simple-to-understand, custom risk score, predicting which adult patients with type 2 diabetes and with chronic kidney disease stages 1-3b are at low, intermediate or high risk for rapid progressive decline in kidney function.

When your clinicians combine information gathered through KidneyIntelX with newer cardio- and reno-protective therapies, it’s a win-win. They will know which patients are at higher to lower risk for rapid disease progression, and therefore, can appropriately target resources and medications shown to be more effective at slowing or preempting disease progression and advancing kidney health.

Here’s how our 3-part, proprietary methodology – bioprognosisTM for kidney health – works:

KidneyIntelXTM has received Breakthrough Device Designation from the FDA for Chronic Kidney Disease Prognosis

1

Proprietary biomarkers

Biological factors that are clinically proven – in multiple studies – to be most prognostic for kidney disease (TNFR-1, TNFR-2, KIM-1).

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

Machine learning combines these diverse and proprietary data inputs to maximize their value through a patient risk score

4

Yields a clear and actionable test report:

Risk score + guideline-recommended clinical pathway

Low
Intermediate
High
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Now, you can more fully understand risk.
Reliably, efficiently, simply.

KidneyIntelX yields a clinically-validated, simple-to-understand, customized risk score, identifying patients upstream who are at low, intermediate or high risk for rapid progressive decline in kidney function. With this, you’ll have more confidence in knowing which patients need lower-level maintenance or ongoing monitoring or need immediate lifestyle and therapeutic adjustments and referrals to a specialist.

Maintain

~50%

of patients are expected to have a low-risk score

Patients are likely to have stable kidney function over the next five years

Follow up at least annually

Monitor

~35%

of patients are expected to have an intermediate-risk score

Patients are at average risk for progression to ESKD

May need modification and a specialist consultation

Follow-up at least 2x year

Act

~15%

of patients are expected to have a high-risk score

Patients at elevated risk for progression to ESKD

Will require aggressive lifestyle changes, medication management and specialist referrals

With KidneyIntelX, clinicians and health systems are in the driver’s seat.

Take Control

Manage CKD in stages 1-3b through a PCP-driven approach

Take Control

Through reliable & actionable risk stratification

Take Control

Make better decisions as to which patients can benefit most from therapeutics

Take Control

By deploying resources most efficiently: only the right patients referred to nephrology

Take Control

Drive improved quality of care and HEDIS metrics

Take Control

Better manage ACO, VBC and risk contracts by improving preemptive, upstream care.

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KidneyIntelX is the one that helps PCPs get it right.

KidneyIntelX is the only bioprognostic methodology for demonstrated risk assessment of adult patients with type 2 diabetes and chronic kidney disease stages 1-3b.

  • Low scoring patients have an approximate 95% chance of not experiencing DKD progression1,2
  • High scoring patients have an approximate 70% chance of experiencing DKD progression1

Simple to implement within your standard of care.

Easy to start.

A non-fasting and simple blood test is all it takes to risk stratify your patient base.

Easy to find out who needs more or less attention.

The KidneyIntelX test provides an highly-reliable, meaningful risk score and the confidence to know whether your patient is at low, intermediate or high risk for progression.

Easy to know what to do next.

Each risk score test report is very simple to understand and comes with a suggested patient-specific, actionable care path based on guideline recommendations.

Simple to order
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1https://www.kidney.org/kidneydisease/global-facts-about-kidney-disease
2Foreman KJ, Marquez N, Dolgert A, Fukutaki K, Fullman N, McGaughey M, et al. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: Reference and alternative scenarios for 2016–40 for 195 countries and territories. Lancet. 2018; 392 (10159): 2052–2090. 10.1016/S0140-6736(18)31694-5 [PMC free article] [PubMed] [CrossRef] [Google Scholar] 3https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease