LONDON: Renalytix AI plc, an artificial intelligence-enabled in vitro diagnostics company, announced a partnership with the University of Michigan to extend the application of the KidneyIntelX platform to an expanded population of patients with established Chronic Kidney Disease (CKD) or at risk of developing CKD.

RenalytixAI also announces a data sharing agreement with a top ten global pharmaceutical company.

RenalytixAI has entered into a partnership with the University of Michigan (UM) under which RenalytixAI will be given access to the Clinical Phenotyping Resource and Biobank Core (C-PROBE) of the UM George M. O’Brien Kidney Translational Core Center comprising of over 800 patients with a broad etiology of CKD with up to 10 years of follow up.

Additionally, through this partnership, RenalytixAI has obtained an exclusive option under which it can license certain intellectual property surrounding the biomarker urinary Epithelial Growth Factor (uEGF). Prof. Mattias Kretzler and his team at UM have shown uEGF to be highly predictive of incident and progressive CKD1.

The first phase of the partnership with UM, expected to be completed in 2020, will study the potential role of uEGF in further enhancing the prognostic performance of the KidneyIntelX platform in identifying patients at highest risk of fast-progressing Diabetic Kidney Disease (DKD) and kidney failure. Significantly, through this partnership, RenalytixAI plans to advance the development and validation of the KidneyIntelX platform for expanded use in a broad CKD population.

The C-PROBE biobank provides RenalytixAI with access to a large repository of longitudinally followed CKD patients with matched urine and plasma samples coupled with extensive medical records. The patient population in the C-PROBE study includes a range of CKD subtypes including those related to Diabetes, Hypertension and Glomerular Disease which combined, account for over 75%2 of all cases worldwide.

RenalytixAI also announced that it has entered into a data sharing agreement with a top ten global pharmaceutical company providing RenalytixAI with access to a deep data repository from completed clinical studies in DKD.

RenalytixAI plans to analyze this data in combination with corresponding biomarker data to evaluate KidneyIntelX performance in predicting patients’ responses to novel therapeutic agents indicated to slow or prevent kidney function decline. Data analysis will also include evaluation of KidneyIntelX over multiple time points within a six year follow-up period, potentially demonstrating the value of dynamic, repeated KidneyIntelX measurements.

Prof. Matthias Kretzler, Professor of Computational Medicine & Bioinformatics and Internal Medicine at UM stated: “The primary aim of our research has always been the translation of findings to clinical practice in order to improve patient care and kidney health. The C-PROBE cohort was established with the express aim of enabling this translation to take place. We are very excited to partner with RenalytixAI in this endeavor and firmly believe that KidneyIntelX platform is an ideal vehicle to integrate the results of our work on uEGF with other biomarkers, bioinformatics and clinical research, with the goal of providing new, powerful solutions in managing CKD.”

Fergus Fleming, Chief Technology Officer and Co-founder of RenalytixAI stated: “These partnerships are both significant developments for our technology development roadmap and strategic objectives for the company. Access to these data sets and samples potentially demonstrates the value of the KidneyIntelX platform and our ability to collaborate with leaders in discovery, clinical care and novel therapeutic development for kidney disease.  We expect that gaining access to this clinical trial data, biomarker technology and the C-PROBE cohort will be key milestones in the development of expanded indications for KidneyIntelX, potentially allowing us to offer solutions to a greater number of the approximately 37 million patients currently estimated to have CKD.”

KidneyIntelX is a first-in-class in vitro diagnostics platform that employs a proprietary artificial intelligence-enabled algorithm to combine diverse data inputs including validated blood-based biomarkers, a patient’s genetics and extensive personalized patient data from EHR systems to generate a unique patient risk score. The current intended use for the test targets patients with CKD and type 2 diabetes which accounts for 20-30% of the estimated 37M US patients with CKD.