What is KidneyIntelX™?
KidneyIntelX is a Laboratory Developed Test that employs bioprognosis™ and a proprietary machine learning-enabled algorithm. It starts with a standard blood draw with a lavender top K2EDTA tube and is a quantitative electrochemiluminescence immunoassay using a MESO SECTOR S 600 instrument for measurement of 3 blood-based biomarkers: soluble Tumor Necrosis Factor Receptor-1 (TNFR1), soluble Tumor Necrosis Factor Receptor-2 (TNFR2), and Kidney Injury Molecule-1 (KIM-1), which are closely correlated with subclinical inflammation and kidney tubular injury.
KidneyIntelX combines these three blood-based biomarkers with seven clinical data inputs from a patient’s medical record (eGFR, UACR, serum calcium, HbA1c, systolic blood pressure, platelets, and AST) to generate a custom risk score that indicates whether an adult patient is at low, intermediate, or high risk of rapid progressive decline in kidney function. In addition to the patient’s risk score, each test report provides an actionable, guideline-recommended care path for both the physician and the patient.
What is the indicated use for the KidneyIntelX test?
KidneyIntelX is indicated for use as an aid to further assess the risk of progressive decline in kidney function within a period of up to 5 years in adult patients with type 2 diabetes and existing chronic kidney disease.
Patients with chronic kidney disease will have an estimated Glomerular Filtration Rate [eGFR] of 30-59 ml/min/1.73m2 [G3a, G3b] or an eGFR ≥ 60 with albuminuria [UACR] ≥ 30 mg/g [A2, A3] stages (1-3).
- Stage 1: eGFR ≥90 ml/min/1.73m2 and a UACR level ≥30 mg/g
- Stage 2: eGFR ≥60-89 ml/min/1.73m2 and an UACR level ≥ 30 mg/g
- Stage 3: eGFR between 30-59 ml/min/1.73m2, regardless of the albumin level
What specific prognostic biomarkers are being used for KidneyIntelX testing?
KidneyIntelX is a prognostic test that incorporates inputs from three (3) well studied biomarkers from human plasma:
- TNFR1: soluble Tumor Necrosis Factor Receptor-1
- TNFR2: soluble Tumor Necrosis Factor Receptor-2
- KIM-1: Kidney Injury Molecule-1
The three biomarkers are accurately measured using an analytically validated electrochemiluminescence immunoassay on a Mesoscale Sector S 600 instrument at CLIA certified Renalytix laboratories. The immunoassay is approved by the New York State Department of Health.
What are the clinical data points that are included in the KidneyIntelX test result?
Along with the values of the 3 proprietary biomarkers that we measure in the Renalytix lab, we also incorporate the values for the following clinical inputs:
- Serum Calcium
- Systolic Blood Pressure
If there is not a UACR, serum calcium, platelets, or AST value, then the values will be “imputed” to represent the population mean for one or all 4 of these clinical inputs. We have data which demonstrates a non-significant impact on the risk score if this approach is used in the subset of individuals that do not have these clinical inputs.
How is progression of kidney disease defined?
The KidneyIntelX test was validated in an analysis of 1146 adult patients with type 2 diabetes selected from two independent cohorts with chronic kidney disease that are representative of patients in the intended use population (adult patients with type 2 diabetes and chronic kidney disease stages 1-3).
For the KidneyIntelX validation studies , progression was defined by 3 criteria:
- A rapid decline in kidney function (eGFR slope ≥5 ml/min/1.73m2)
- A ≥40% decline in kidney function from time zero that is sustained (confirmed at least 3 months later)
- “Kidney failure” is defined as a sustained level of eGFR < 15 ml/min/1.73m2 (consistent with stage 5 CKD/DKD), the need for long-term dialysis (either hemodialysis or peritoneal dialysis), or the receipt of a kidney transplant.
What is the benefit of ordering a KidneyIntelX test if my patient’s CKD is under control?
When doctors combine patient information gathered through KidneyIntelX with newer cardio- and reno-protective therapies, it’s a win-win. They will be able to confirm which patients are at higher to lower risk for rapid kidney disease progression, and therefore, can appropriately continue to target resources, medications, and guideline-recommended treatments to advance kidney health.
Is there an age range?
KidneyIntelX is indicated for use in adult patients 21 years of age and older.
Can I use this test on non-diabetics?
No. KidneyIntelX is an aid to further assess the risk of progressive decline in kidney function for adult patients with type 2 diabetes and early-stage chronic kidney disease.
How will KidneyIntelX benefit my practice and my patients?
After adult patients with type 2 diabetes are screened for kidney disease, you will still need to identify which of those patients will need lower-level maintenance or ongoing monitoring or immediate lifestyle and therapeutic adjustments and referrals to a specialist.
KidneyIntelX yields a clinically validated, simple-to-understand, custom risk score, identifying adult diabetic patients with chronic kidney disease in stages 1-3 who are at low, intermediate, or high risk for rapid kidney disease progression over the next five years.
Our 3-part, proprietary methodology – bioprognosis™ for kidney health – predicts risk and outcomes to promote and preserve kidney health.
With one simple blood test, you will receive your patient’s custom risk score with actionable, guideline-recommended treatment steps.
Why is KidneyIntelX a more advanced measure for risk of CKD progression in adult type 2 diabetes patients than UACR or eGFR alone?
Existing measurements do not predict disease progression for two primary reasons:
1. Biological variability at the patient level.
There is too much fluctuation present when using eGFR and UACR as the core measurements for kidney disease progression. For these to be reliable metrics to ascertain kidney disease staging, the patient results would need to be consistent from week to week. Studies indicate that this is not the case.
Hyperfiltration plays a critical role in chronic kidney disease in diabetes as it puts stress on the filtration barrier and post-filtration mechanisms.
The increased flow increases the delivery and reabsorption of small and large molecular weight solutes resulting in injury to the kidneys.
Despite significant damage to some of the kidney’s tissue, the remaining tissue compensates, trying to preserve kidney function. That’s why, even when testing eGFR and urine albumin, kidney function levels can look normal, which may lead to a false sense of security.
That is why doctors should continue to use current measurements to diagnose chronic kidney disease and add the KidneyIntelX test to predict adult patients with type 2 diabetes and with chronic kidney disease stages 1-3 who are at low, intermediate, or high risk for rapid progressive decline in kidney function.
How will I get the results?
You should receive the KidneyIntelX test report in approximately 5-7 days. For those without electronic health record integration (EHR), results will be delivered through a secure channel.
Who will get my patient’s results?
The ordering physician will receive the KidneyIntelX test report which includes a patient-specific risk assessment score and a guideline-recommended care path.
HOW SHOULD I INTERPRET THE KIDNEYINTELX RISK SCORE?
What does a low-risk test result mean?
A KidneyIntelX score of ≤45 is classified as low-risk or “green”. In the clinical validation study, the low-risk patient group averaged a 10% probability of progressive decline in kidney function over 5 years compared to the intermediate-risk and high-risk groups that averaged a 22% and 61% probability, respectively. 5-6
What are the clinical recommendations for a low-risk test result?
The clinical pathway recommendation was based on the following guidelines: American Diabetes Association Standards of Medical Care in Diabetes 2022, KDIGO 2020 Clinical Practice Guideline for Diabetes Management in CKD, VA/DoD Clinical Practice Guidelines- Management of CKD (2019) and KDIGO 2012 Clinical Practice Guidelines for the Evaluation and Management of CKD.
Each health care system will have their own clinical pathway recommendations. Subject matter expert physicians recommend a comprehensive strategy to reduce diabetic kidney disease progression and cardiovascular disease which include: