Renalytix plc announced the launch of PRIME-CKD, a consortium of industry, academic and clinical research leaders, that aims to validate and implement in clinical practice, novel biomarker-based tests that predict response to existing drugs used by patients with chronic kidney disease (CKD). PRIME-CKD is funded by Horizon Europe, the European Union's key funding program for research and innovation. The total budget of the project is $10 million over a projected five-year period with approximately 10% of the budget targeted for commercial translation activities to be undertaken by Renalytix.

The company expected the project to benefit from Renalytix's substantial expertise in biomarker research translation and existing intellectual property on urinary Epidermal Growth Factor (uEGF) for which Renalytix has exclusive access from the University of Michigan. The project is closely aligned with Renalytix's objective of expanding the clinical utility of the KidneyIntelX platform beyond prognosis to prediction and monitoring of drug response. The consortium brings together leading experts from 11 academic institutions, together with partners from patient representative foundations and regulatory agencies.

The PRIME-CKD consortium is committed to demonstrating the utility of novel biomarkers as tools for better selection of drug therapies for patients, for use both in daily clinical practice and innovative clinical trials. Notably, if certain biomarkers are successful, the PRIME-CKD program will seek qualification of these biomarkers through the European Medicines Agency and the United States Food and Drug Administration (FDA) for this purpose. Kidney disease is a public health epidemic affecting over 850 million people globally.

The Centers for Disease Control and Prevention estimates that 15% of U.S. adults, or approximately 37 million people, have chronic kidney disease (CKD). Nearly 95% of people with CKD are in early stages 1-33. Despite its magnitude, early-stage (1-3) CKD is underdiagnosed and undertreated, largely because it's asymptomatic at this time in the disease.

As many as 9 in 10 adults with CKD, and about 2 in 5 adults with severe CKD do not know they have the condition.