RenalytixAI will assess its lead product, the AI-enabled kidney disease diagnostic KidneyIntelX, in more than 3,500 patients with Type II diabetes through a collaboration with University Medical Center Groningen (UMCG) in the Netherlands.
The value of the collaboration was not disclosed.
The study will be designed to assess how effectively the KidneyIntelX test identifies patients with fast-progressing kidney disease who would be most likely to benefit from new drug therapies to prevent or slow down their progression to end-stage renal disease and dialysis, RenalytixAI said.
KidneyIntelX will be performed at multiple time points on over 9,000 patient samples from completed clinical trial biobanks, with the aim of generating insights into the potential utility of KidneyIntelX as a predictor of response to breakthrough therapies for treating diabetic kidney disease.
Initial data from the collaboration is expected to be published in early 2020. That data is expected to support prospective revenue-generating clinical trial and clinical diagnostic applications of KidneyIntelX.
RenalytixAI Better identification and characterization1 of enrolled patients has the potential to reduce the cost and duration of clinical trials and increases the likelihood of reaching successful outcomes.
“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,” Hiddo J.L. Heerspink, Pharm.D., Department of Clinical Pharmacy and Pharmacology, UMCG and lead investigator in the planned evaluation, said in a statement. “Additionally, the potential to predict drug response in these patients is critically important to directing clinical use of new therapies.”
KidneyIntelX is designed to diagnose and improve clinical management of patients with Type II diabetes and those of African ancestry with fast-progressing kidney disease.
RenalytixAI’s technology platform is designed to apply analysis by machine learning computer algorithms of patient data from sources such as large electronic health records, and genomic information that includes three predictive blood-based biomarkers, tumor necrosis factor receptor 1 and 2 (TNFR1 and TNFR2) and kidney injury molecule 1 (KIM-1).
RenalytixAI expects to commercially launch KidneyIntelX as a laboratory developed test in its CLIA lab facilities in the U.S. in the second half of this year. KidneyIntelX received the FDA’s Breakthrough Device designation on May 2.
Based in New York, RenalytixAI is a developer of AI-enabled clinical diagnostics for kidney disease. The company says it intends to build a deep, unique pool of kidney disease-related data for different AI-enabled applications designed to improve predictive capability and clinical utility over time.
In February, RenalytixAI signed a partnership agreement with AKESOgen, a commercial laboratory facility and provider of clinical trial precision medicine services in Atlanta. The agreement created a joint venture, RENX AI Labs, that was created to provide services directly to health systems and pharmaceutical companies located in all regions of the U.S.
The joint venture was intended to support prospective revenue-generating contract research, clinical diagnostic and clinical trial services that are part of the company’s core business model with KidneyIntelX and other products under development.