KidneyIntelX Testing For Patients With CKD And Type 2 Diabetes

Globally, more than 850 million people have chronic kidney disease (CKD). In the United States, it affects more than 37 million (15% of the adult population). 15 million of these patients have both CKD and diabetes type 2. There is a rapid need for early disease assessment, diagnosis and treatment. If not addressed at an early stage, significant kidney function loss can develop.

Traditional kidney testing is often unreliable. “Standard risk stratification tools for progression of kidney disease have limitations, and lack precision at an individual level.” Every patient and every kidney disease are different. Until now, it has been difficult to assess whether a patient will progress at a low-risk or a high-risk rate.

KidneyIntelX (created by Renalytix) can reliably help patients understand their exact risk. It “yields a simple-to-understand, custom risk score, identifying adult patients with type 2 diabetes and chronic kidney disease stages 1-3b, who are at low, intermediate or high risk for rapid progressive decline in kidney function.”

KidneyIntelX uses quantitative immunoassay (used to measure the amount of  therapeutic products in a biologic matrix, such as plasma or serum) and clinical data combined with a machine learning algorithm to find a specific score for a patient’s 5 year risk for disease progression or decline.  *KidneyIntelX has received breakthrough device designation from the U.S. Food and Drug Administration (FDA).

Test reports and risk assessment:

• Low-risk (KidneyIntelX score of 5-45): approximately 50% of patients are expected to receive this score. Type 2 diabetes and CKD stages 1-3b. Lowest risk for decline in kidney function (less than 10% over a 5 year period).
• Intermediate-risk (KidneyIntelX score of 50-85): approximately 35% of patients will receive this score. These patients should monitor “kidney health more frequently, which may include additional visits, additional blood work, some lifestyle changes and potentially, the introduction of specialized medication.”
• High-risk (KidneyIntelX score of 90-100): approximately 10% of patients will receive this score. This results in a 60% change of progressive decline in kidney function over the next 5 years. With this score, patients should act more “quickly and aggressively” with treatment. Maximize current medication and also try newer medication.

Testing with KidneIntelX is done during CKD stages 1-3b. This allows doctors and patients the appropriate amount of time to alter treatment plans if needed. “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 rapid progressive decline in kidney function vs current standard of care.”

See commonly asked questions HERE.
Payment and insurance options HERE.
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