Renalytix test gets US FDA marketing authorisation
Renalytix (Reg S)
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16:55 20/12/24
Renalytix announced on Friday that the US Food and Drug Administration (FDA) had granted De Novo marketing authorisation for its ‘KidneyIntelX.dkd’ prognostic test.
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The AIM-traded firm said the milestone achievement solidified KidneyIntelX as the first-of-its-kind, artificial intelligence-enabled prognostic testing platform.
It said the platform was designed to guide care management for adults with type-2 diabetes and early-stage chronic, diabetic, kidney disease.
"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 chief executive officer James McCullough.
"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."
At 1530 BST, shares in Renalytix were up 41.03% at 105.78p.
Reporting by Josh White for Sharecast.com.