FDA grants De Novo Marketing Authorization for KidneyIntelX.dkd to assess risk of progressive kidney function decline in adults with diabetes and early-stage kidney disease.- Renalytix plc.

Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals.

KidneyIntelX.dkd accurately stratifies patients into three risk levels (low, moderate, and high). This result provides comprehensive information on patient risk for progressive decline in kidney function within five years, independently of the current standard of care measures. KidneyIntelX.dkd is the name used to differentiate tests to be provided under the De Novo marketing authorization by the FDA from those provided under the KidneyIntelX name as a Laboratory Developed Test.

“Meeting the rigorous safety, clinical and analytical validation, and scientific data requirements of an FDA review, from Breakthrough Device designation to De Novo marketing authorization, is a landmark event for health care providers and patients with diabetic kidney disease,” said James McCullough, CEO of Renalytix. “With this approval a new class, Prognostic Test for Assessment of Chronic Kidney Disease Progression, has been established by the FDA, providing a roadmap for future expansion of KidneyIntelX into new indications and products.”