KidneyIntelX is a Laboratory Developed Test (LDT) that yields a custom risk score identifying adult patients with type 2 diabetes and with 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.
Renalytix is seeking FDA De Novo marketing authorization for KidneyIntelX. The test is not FDA approved nor cleared for any use at this time.