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Renalytix is seeking FDA De Novo marketing authorization for KidneyIntelX. The test is not FDA approved nor cleared for any use at this time. KidneyIntelX yields a custom risk score that identifies which adult diabetic patients in early stages of chronic kidney disease are at low, intermediate or high risk for rapid progressive decline in kidney function within a period of up to five years. To report a product concern or suspected Adverse Event, please contact Renalytix Client Service at 1-888.203.2725.