NEW YORK (360Dx) — RenalytixAI said today that it has partnered with the University Medical Center Groningen (UMCG) in the Netherlands to evaluate its KidneyIntelX kidney disease test in a 3,500-patient clinical study.
KidneyIntelX is designed for the management of type 2 diabetes patients and uses machine learning algorithms to assess predictive blood-based biomarkers — including sTNFR1, sTNFR2, and KIM1 — and electronic health record information to identify progressive kidney disease. It received a Breakthrough Device designation from the US Food and Drug Administration earlier this month.
According to Cardiff, Wales-based RenalytixAI, the trial will evaluate KidneyIntelX's ability to identify fast-moving kidney disease in 3,500 type 2 diabetics. The test will be performed at multiple timepoints on over 9,000 patient samples from completed clinical trial biobanks.
"The ability of KidneyIntelX to discriminate fast progressing kidney disease offers pharma the potential to enrich clinical trials with patients most likely to benefit most from novel drug therapies," UMCG's Hiddo Heerspink, the lead investigator of the study, said in a statement. "Additionally, the potential to predict drug response in these patients is critically important to directing clinical use of new therapies."
RenalytixAI said that data from the trial are expected to be published in early 2020, supporting prospective revenue-generating clinical trial and clinical diagnostic applications of the test.
Earlier this year, RenalytixAI formed a joint venture with Akesogen to provide products and services — beginning with KidneyIntelX — directly to health systems and pharmaceutical companies located in the US.