RenalytixAI, a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, today announced that it 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.
FDA Breakthrough Devices Program Overview
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.
Impact of Kidney Disease in the United States
Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. In the United States alone, over 40 million people are classified as having chronic kidney disease, with nearly 50 percent of individuals with advanced (Stage IV) disease unaware of the severity of their reduced kidney function. As a result, many patients progress to kidney failure in an unplanned manner, ending up having dialysis in the emergency room without ever seeing a clinical specialist, such as a nephrologist. Every day 13 patients die in the United States while waiting for a kidney transplant.
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. KidneyIntelXTM is being developed in close collaboration with the Mount Sinai Health System.
Why It Matters
“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,” said Sally Bowden, chief operating officer, RenalytixAI. “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.”