Study to begin on new diagnostic tool for tracking CKD progression
RenalytixAI plc is beginning a clinical validation study for KidneyIntelX, a diagnostic tool designed to use artificial intelligence to diagnose and improve clinical management of patients with type 2 diabetes and those of African ancestry with rapidly progressing kidney disease.
According to a company press release, a multicenter investigator group from Mount Sinai Health Systems, Harvard University, Johns Hopkins Medicine, Northwestern University and others, will track 5,000 patients using the tool. KidneyIntelX applies machine learning algorithms to assess the combination of predictive blood-based biomarkers and other genomic information in combination with information from electronic health records to help predict disease progression and drug/therapy response in individual patients.
In June 2018, Mount Sinai and RenalytixAI entered into a multiyear license and collaboration agreement to use artificial intelligence (AI) to improve chronic kidney disease detection, management and treatment for patients with diabetes and for other at-risk, large-scale patient populations.
“What AI will allow us to do is identify those at risk of CKD early and allow us to stratify patients with regard to risk for progression of CKD,” Barbara Murphy, MD, MB, BAO, BCh, FRCPI, chair of the department of medicine, the Murray M. Rosenberg Professor of Medicine, and dean for clinical integration and population health at the Icahn School of Medicine at Mount Sinai, told Healio/Nephrology last year. “It will guide early identification, management and monitoring of patients.” Approximately 1 million patients cared for in the Mount Sinai Health System are either diagnosed with type 2 diabetes or are of African ancestry.
RenalytixAI has raised $29 million from a network of institutional and industry health care investors to help launch the validation study. The company, a Mount Sinai licensee and development collaborator, works to develop and commercialize clinical diagnostic solutions for early detection of kidney disease and transplant management, according to a Mount Sinai release.
RenalytixAI said in the release that it expects to commercially launch KidneyIntelX to health systems and drug developers in the second half of 2019. The validation data will also be used to support the submission of KidneyIntelX for FDA review in 2019.