Renalytix AI plc has received an FDA Breakthrough Device Designation for KidneyIntelXTM, its main diagnostic test for kidney disease.
The device is designed to diagnose and improve clinical management of patients with type-2 diabetes with fast-progressing kidney disease. Using machine-learning algorithms, KidneyIntelX will assess the combination of predictive blood-based biomarkers, including sTNFR1, sTNFR2 and KIM1, with electronic health record information, to identify progressive kidney disease.
Globally, kidney disease is recognized as a public health epidemic affecting more than 850 million people, making its early detection and intervention crucial. The annual cost of chronic and end-stage kidney disease to the U.S. health care system is estimated to be $114 billion. Each day, 13 patients die in the U.S. while waiting for a kidney transplant.
Source: Renalytix AI plc, May 2, 2019