Friday, June 30, 2023
Renalytix plc has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. This groundbreaking development establishes KidneyIntelX as the first-in-class prognostic testing platform, utilizing artificial intelligence (AI), to guide care management for adults with type 2 diabetes and early-stage chronic kidney disease. Renalytix anticipates that FDA authorization will drive increased test adoption, influence clinical guidelines, expand insurance coverage, and pave the way for further international regulatory approvals.
According to James McCullough, CEO of Renalytix, obtaining FDA approval signifies a significant milestone, as it validates the safety, clinical validation, and scientific data of KidneyIntelX through a rigorous review process. This approval establishes a new class of prognostic test for the assessment of chronic kidney disease progression, paving the way for future expansions of KidneyIntelX into new indications and products.
KidneyIntelX.dkd effectively stratifies patients into low, moderate, and high-risk categories, providing comprehensive information on the risk of progressive decline in kidney function within five years, independent of current standard of care measures. It should be noted that KidneyIntelX.dkd is the specific name designated for tests provided under the FDA's De Novo marketing authorization, differentiating them from the Laboratory Developed Tests offered under the KidneyIntelX name.
KidneyIntelX has already reported results for approximately 10,000 patients in the United States. The test has garnered broad insurance payment coverage, including from Medicare and numerous private payers.
The KidneyIntelX platform combines blood-based biomarkers with clinical variables, leveraging AI algorithms to deliver reliable and actionable information for guiding care in large populations at risk. The technology behind KidneyIntelX was developed at the Icahn School of Medicine at Mount Sinai in New York and subsequently licensed to Renalytix.