FDA Grants Breakthrough Device Designation to KidneyIntelX

Renalytix AI plc, a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX. This is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company.
 
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 $114 billion annual cost¹ of chronic and end-stage kidney disease to the United States healthcare system. The 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. KidneyIntelX is being developed in close collaboration with the Mount Sinai Health System.
 
The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.
 
Sally Bowden, Chief Operating Officer of RenalytixAI, said, “This designation is a significant advancement towards our goal of bringing to market a solution that can greatly improve the identification and treatment of patients with chronic kidney disease. We look forward to continuing to work closely with the FDA through this process, including on our data development plan, our clinical validation and our subsequent submission for regulatory clearance.”
 
Erik Lium, Ph.D., Executive Vice President of Mount Sinai Innovation Partners, said, “We’re pleased RenalytixAI has received Breakthrough Designation for KidneyIntelX, providing the opportunity to work hand-in-hand with the FDA towards the goal of FDA submission. Renal disease represents an increasing healthcare crisis globally, and early detection and intervention is essential in changing the course of this disease.”
 
Reference
¹ United States Renal Data System – https://www.usrds.org/adrhighlights.aspx.