We help clinicians
advance kidney health.
At Renalytix, our singular goal is to eradicate kidney disease. To that end, our Renalytix laboratories are dedicated to delivering highly-reliable, risk score results that help clinicians predict 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.
Results are delivered via the company’s product offering, KidneyIntelX™, which has been validated in two large cohorts, and has received FDA Breakthrough Device Designation.
When doctors 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 kidney disease progression, and therefore, can appropriately target resources and guideline-recommended treatments to advance kidney health.
Evidence highlights include:
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.
2Lam D, Nadkarni GN, Mosoyan G, et al. Clinical Utility of KidneyIntelX in Early Stages of Diabetic Kidney Disease in the CANVAS Trial. Am J Nephrol. 2022;53(1):21-31.
