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 (TNFR1, TNFR2, 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 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.

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