AI clinical diagnostic company Renalytix AI plc (LON:RENX) reported on Thursday the receipt of the US Food and Drug Administration's (FDA) Breakthrough Device designation for its lead AI-enabled diagnostic for kidney disease, KidneyIntelX.

According to Renalytix, this is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company. KidneyIntelX is being developed in close collaboration with the Mount Sinai Health System.

The KidneyIntelX is designed to diagnose and improve clinical management of patients with Type II diabetes with fast-progressing kidney disease, in an effort to curtail the estimated USD114bn annual cost of chronic and end-stage kidney disease to the United States healthcare system.

The KidneyIntelX diagnostic will use machine learning algorithms to assess the combination of predictive blood-based biomarkers, including sTNFR1, sTNFR2 and KIM1, in combination with electronic health record information, to identify progressive kidney disease.