RenalytixAI, New York, has received a clinical laboratory permit from the New York State Department of Health (NYS DOH) to provide commercial testing of KidneyIntelX, an artificial intelligence-based in vitro diagnostic that can identify patients at the highest risk of progressive decline in kidney function in early stage diabetic kidney disease with higher accuracy than existing care methods.
The permit was granted following an extensive review of the analytical and clinical validation results for KidneyIntelX. Effective immediately, KidneyIntelX may now be used to report risk assessment results for fast-progressing kidney disease and future kidney failure for patients with type 2 diabetes and chronic kidney disease. With this approval, RenalytixAI will move to complete its full commercial launch of KidneyIntelX with Mount Sinai Health System and expects to begin reporting patient results in the third quarter of this calendar year.

KidneyIntelX is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment of progressive kidney function decline within a period up to 5 years.

For more information, visit RenalytixAI.