Med-tech firm Renalytix AI PLC (LON:RENX) said positive results from a study designed to validate the potential of its KidneyIntelX diagnostic will be submitted to the US Food & Drug Administration.
The technology, which has been given breakthrough device designation by the FDA, uses artificial intelligence to help doctors by improving the identification, prediction, and risk stratification of patients with progressive disease.
The latest data is being presented to the American Diabetes Association, which runs from June 12-16.
Online delegates will be told the expanded validation study showed KidneyIntelX was able to identify patients at the highest risk of early-stage diabetic kidney disease with more accuracy than existing care methods.
The primary objective of the assessment was to demonstrate if the artificial intelligence-enabled algorithm was able to predict which patients at the highest risk of “adverse kidney outcomes" with more accuracy than the current approach.
The optimised KidneyIntelX assay, combining measurements of biomarkers soluble tumour necrosis factor receptor and kidney injury molecule-1 and clinical data from electronic health records, achieved a 62% positive predictive value in the top 16% of the population.
This compared with a PPV of 41% for the standard of care.
In Wednesday’s release, Renalytix said it would provide further updates on the FDA submission process “in the near term as appropriate”.
It added that the latest data will also support the “ongoing commercialisation” of its breakthrough technology.
KidneyIntelX is being developed to help more than 12 million Americans with diabetic kidney disease (DKD).
“While only 20% of patients with DKD will experience progression over a five-year period, DKD accounts for nearly half of all cases of end-stage kidney disease ESKD,” the company said.