FDA Grants Marketing Authorization of KidneyIntelX.dkd

Breaking news for the CKD community!

The PRIME-CKD consortium is proud to have on board Renalytix as partner. The FDA has granted marketing authorization to Renalytix techonology KidneyIntelX.dkd. This is an innovative prognostic test that guides care mangement for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease.

KidneyIntelX.dkd accurately 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. We plan to explore use of the KidneyIntelX platform to incorporate additional information on baseline risk into analysis of clinical findings.

We are looking forward to many years of collaboration to bring precision medicine to diabetes and CKD. We are one step closer in bringing these innovative solutions to the CKD patients and CKD care.

You can find more information about this fantastic achievement here