Renalytix plc (NASDAQ:RNLX) shares are gaining after the FDA granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test to assess the risk of progressive kidney function decline in adults with diabetes and early-stage kidney disease.

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

KidneyIntelX.dkd is the name used to differentiate tests to be provided under the De Novo marketing authorization by the FDA from those provided under the KidneyIntelX name as a Laboratory Developed Test.

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

Using an artificial intelligence-enabled algorithm, the KidneyIntelX platform combines blood-based biomarkers with clinical variables, providing reliable and actionable information. 

KidneyIntelX is based on technology developed at the Icahn School of Medicine at Mount Sinai in New York, NY, and licensed to Renalytix.

Cash and cash equivalents totaled $33.0 million as of March 31, 2023.

During the three months ended March 31, 2023, the company recognized $0.7 million of revenue (Q3 FY22: $0.8 million).

Price Action: RNLX shares are up 41.10% at $2.92 during the premarket session on the last check Friday.