Simple Blood Test Aids Risk Assessment for Approximately 14 Million Eligible Patients in the United States
Diabetic Kidney Disease is the Leading Cause of End Stage Kidney Disease in the US. (Credit: Robina Weermeijer on Unsplash)
Renalytix announces that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease. Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals.
“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.”
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.
Since being introduced as a Laboratory Developed Test (LDT), KidneyIntelX results have been reported on approximately 10,000 patients in the United States and there has been broad insurance payment including from Medicare and many private payers.
The KidneyIntelX platform combines blood-based biomarkers with clinical variables using an artificial intelligence enabled algorithm, providing reliable and actionable information to guide care in large, at-risk patient populations. KidneyIntelX is based on technology developed at the Icahn School of Medicine at Mount Sinai in New York, NY, and licensed to Renalytix.
Source: Company Press Release