Renalytix PLC on Friday said the US Food & Drug Administration has granted marketing authorisation for its KidneyIntelX.dkd prognostic testing platform.
Shares in Renalytix jumped by 63% at 121.90 pence each in London on Friday morning.
The London-based kidney health-focused diagnostics company said the FDA’s approval will lead to increasing test adoption, insurance coverage, and additional international regulatory approvals.
KidneyIntelX.dkd platform is used for type two diabetes and kidney disease care management.
Chief Executive Officer 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.’
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