Have a question?
Here are some frequently asked questions that we receive at Renalytix Laboratories.
If you have more questions about KidneyIntelX™, click here to visit our product website.
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 MESO SECTOR S 600 instrument for measurement of 3 biomarkers: soluble Tumor Necrosis Factor-1 (TNFR1), soluble Tumor Necrosis Factor-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 to generate a custom risk score that indicates whether a patient is at low, intermediate, or high risk of 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 patient.
Has KidneyIntelX™ been evaluated by the FDA?
Not yet. Renalytix is voluntarily pursuing a rigorous FDA review and marketing authorization process for KidneyIntelX™. KidneyIntelX™ has received FDA Breakthrough Device Designation and is pending review completion by the agency.
How is KidneyIntelX™ processed in the laboratory?
Once the collection kit is received, it is accessioned into the laboratory information system, collection requirements are assessed, and then the patient specimen is tested using KidneyIntelX™ processes.
The KidneyIntelX™ test process includes:
1. Processing blood to separate plasma from K2EDTA Lavender top blood tube
2. Automated setup of Electrochemiluminescence immunoassay (ECLIA -quantitative method for measurement of antigen or antibody-based on the change in electrochemiluminescence) to measure kidney inflammation and injury biomarkers
3. Analysis of patient historical laboratory data and biomarker measurements
4. Risk score calculation using the proprietary KidneyIntelX™ algorithm
Once the patient specimen arrives at Renalytix Laboratories, how long does it take for the healthcare provider to receive results?
A simple blood test with actionable results are returned to the doctor in approximately five days.
How can I interpret the results?
The KidneyIntelX™ risk score indicates the likelihood that your patient will experience progressive decline in kidney function. There are three reported risk groups:
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, type 2 diabetic patient with stages 1-3 chronic kidney disease 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.
What are the benefits and risks of the KidneyIntelX™ test?
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 progression vs the current standard of care (eGFR and UACR)1.
Where can I get more information?
Please call Renalytix at 1-888.203.2725. For patient information, visit kidneyintelx.com/patients.
Client Service: 1-888-203-2725
KidneyIntelX™ is a Laboratory Developed Test (LDT) that yields a 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 disease progression within a period of up to five years. It is regulated by the Centers for Medicare and Medicaid Services (CMS) in CLIA-certified laboratories. The KidneyIntelX™ test is currently used for clinical and commercial purposes; It should not be regarded as only investigational or for research purposes. KidneyIntelX™ has received FDA Breakthrough Device Designation, though it has not yet been approved by the FDA nor is it currently required to be. That said, Renalytix is voluntarily seeking FDA De Novo marketing authorization.
To report a product concern or suspected Adverse Event, please contact Renalytix Client Service at 1-888-203-2725.
1Chan L, Nadkarni GN, Fleming F, et al. Derivation and validation of a machine learning risk score using biomarker and electronic patient data to predict progression of diabetic kidney disease. Diabetologia. 2021;64(7):1504-1515.