Artificial intelligence-based clinical diagnostics maker Renalytix AI has partnered with University Medical Center Groningen (UMCG) in the Netherlands to study its KidneyIntelX test in type 2 diabetes patients.
KidneyIntelX is an AI-enabled diagnostic intended for the detection and better clinical management of type 2 diabetes patients with fast-progressing kidney disease.
It leverages machine learning algorithms to analyse a combination of predictive blood-based biomarkers, such as sTNFR1, sTNFR2 and KIM1, along with electronic health record information.
Recently, the test secured breakthrough device designation from the US Food and Drug Administration (FDA).
As part of the latest collaboration, the test will be evaluated for its effectiveness to detect patients with fast-progressing kidney disease who could most likely respond to new medications meant to prevent or slow the progression to end-stage renal disease and dialysis.
The study will involve more than 3,500 participants. KidneyIntelX will also be assessed at various time points using more than 9,000 patient samples obtained from completed clinical trial biobanks.
This assessment is expected to offer insight into the potential use of the test in predicting response to the diabetic kidney disease drugs.
Lead investigator Hiddo Heerspink said: “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.
“Additionally, the potential to predict drug response in these patients is critically important to directing clinical use of new therapies.”
Initial findings from the alliance are expected to be published early next year. It is anticipated that the data will support prospective clinical trial and clinical diagnostic applications of the test.
RenalytixAI expects to commercially launch the test at its CLIA laboratory facilities in the US in the second half of this year.