Renalytix AI (AIM:RENX) said positive results of a clinical validation study for its KidneyIntelX diagnostic will be presented at ADA Scientific Sessions 2020 and submitted to the US FDA.
KidneyIntelX is an artificial intelligence in vitro diagnostic product intended to support doctors by improving identification, prediction, and risk stratification of patients with kidney disease.
The group said that a validation study showed KidneyIntelX 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 AI-enabled algorithm could predict which patients are at the highest risk of adverse kidney outcomes with more accuracy than the current approach.
Shares in Renalytix AI closed at 445p on Tuesday afternoon.
The data will support the group’s submission to the FDA for KidneyIntelX under the Breakthrough Device designation which would speed up the technology’s development.
The new data will also support the ‘ongoing commercialisation’ of KidneyIntelX which 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 group said.
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