KidneyIntelX has a growing body of evidence via validation, utility and economic studies, including a demonstrated 72% improvement in predicting those patients who are at high risk for progression vs the current standard of care.
Other offerings use only electronic health data (EHR) and artificial intelligence to fuel their product’s approach.
Conversely, KidneyIntelX starts with a patient blood test (to identify and validate proprietary biomarkers demonstrated to be the most prognostic for rapid kidney disease progression) and combines select clinical data features and machine learning to generate a highly-actionable, patient risk score (low, intermediate, high) coupled with a guideline-recommended, clinical action plan.
By starting in stages 1-3b of diagnosed kidney disease and implementing KidneyIntelX – a test demonstrated to predict which adult patients with type 2 diabetes and with chronic kidney disease stages 1-3b are at more or less risk for rapid progressive decline in kidney function – clinicians and patients will reap the greatest benefits from the rest of the treatment plan.
Many doctors use eGFR exclusively, believing it to be a reliable way to successfully diagnose kidney disease progression. Other doctors add UACR to the equation. Alone or together, these measurements do not fully nor reliably predict adult diabetic patient risk for rapid progressive decline in kidney function. They do, however, diagnose the presence of kidney disease and its current stage. That said, if doctors combine eGFR/UACR with KidneyIntelX, they can both reliably diagnose the disease and predict the likelihood of its rapid progression.
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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.