26th Aug 2020 11:54
(Alliance News) - Renalytix AI PLC on Wednesday said it has filed a submission to get regulatory approval for its KidneyIntelX kidney disease testing product in the US.
The submission for the Food & Drug Administration certification comes after the New York State Department of Health issued a clinical laboratory permit for commercial testing of the product.
"FDA clearance is now being sought for the intended use of KidneyIntelX, in conjunction with clinical evaluation, as an aid to further assess the risk of progressive decline in kidney function within a period of up to five years in patients over the age of 21 with type 2 diabetes and existing chronic kidney disease," the diagnostics company said.
Shares in the company were 2.7% lower at 557.00 pence each in London on Wednesday near midday.
By Eric Cunha; [email protected]
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