Renalytix has received De Novo marketing authorisation from the US Food and Drug Administration (FDA) for its KidneyIntelX.dkd prognostic test.
The artificial intelligence (AI) enabled prognostic testing platform is intended for guiding care management for adults with early-stage chronic (diabetic) kidney disease (CKD) and type 2 diabetes.
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It precisely stratifies patients into low, moderate and high-risk levels.
This outcome offers comprehensive information on patient risk for progressive decline in the function of kidneys within five years.
Using an AI-enabled algorithm, the testing platform integrates blood-based biomarkers with clinical variables to provide actionable information to guide care in large, at-risk patients.
The results of the test were reported on 10,000 patients in the US since it was introduced as a laboratory-developed test.
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By GlobalDataRenalytix has licenced the technology related to KidneyIntelX from the Icahn School of Medicine located at Mount Sinai in New York.
The KidneyIntelX technology platform has been developed to launch new laboratory-developed and FDA-approved tests for adult patients with type 2 diabetes and early-stage CKD.
Renalytix CEO James McCullough said: “Meeting the rigorous safety, clinical and analytical validation and scientific data requirements of an FDA review, from Breakthrough Device designation to De Novo marketing authorisation, is a landmark event for health care providers and patients with diabetic kidney disease.
“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.”
