RenalytixAI has won Break Through Device designation from FDA for KidneyIntelX a technology that could help diagnose kidney disease. This is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company.
KidneyIntelx was designed in an effort to curtail the estimated $114 billion annual cost of chronic and end-stage kidney disease to the U.S. healthcare system.
“The technology is a combination of a multiplex lab-based test measuring three biomarkers (sTNFR1, sTNFR2 and KIM1) that are shown to be prognostic in nature for rapid progression of kidney disease,” Sally Bowden, COO, RenalytixAI, told MD+DI. “This is combined with historical and longitudinal data from the patient’s electronic health records. Using machine learning to derive algorithms combined with biomarker data has shown to be predictive of a patient that has type 2 diabetes to progress to chronic kidney disease.”
Bowden noted that it was an honor to receive Breakthrough Designation from FDA and that the guidance can be beneficial.
“Breakthrough Designation means [FDA] is available through a variety of different channels to review our data development plan; to review our validation protocol; and really provide feedback throughout the design control and clinical validation process," she said. "The importance of having that feedback and having that close relationship with FDA is along the way they’re giving you guidance on what they expect to see in the final submission and they’re there to answer questions.”
The Breakthrough Designation from FDA comes on the heels of RenalytixAI raising $29 million on an IPO. The firm trades publicly on AIM, a market of the London Stock Exchange.