Renalytix Shares Surged 73.9% After FDA De Novo Test Approval

The Renalytix PLC (NASDAQ: RNLX) share price surged 73.9% after revealing that its KidneyIntelX.dkd™ prognostic test had been granted De Novo marketing authorization by the US Food and Drug Administration (FDA).

The approval 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 the FDA authorization will increase test adoption, inform clinical guidelines, expand insurance coverage, and pursue additional international regulatory approvals.

KidneyIntelX.dkd accurately splits patients into three risk levels (low, moderate, and high). The test result provides comprehensive information on patient risk for progressive decline in kidney function within firm years, independently of the current standard of care measures. 

Since being introduced as a Laboratory Developed Test (LDT), KidneyIntelX results have been reported on approximately 10,000 patients in the United States. There has been broad insurance payment, including from Medicare and many private payers.

KidneyIntelX.dkd differentiates tests provided under the De Novo marketing authorization by the FDA from those provided under the KidneyIntelX name as a Laboratory Developed Test.

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.

James McCullough, CEO of Renalytix, 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.”

*This is not investment advice. 

Renalytix (RNLX) share price. 

The Renalytix share price surged 73.91% to trade at $3.60, from Thursday’s closing price of $2.07.