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FDA Awards De Novo Marketing Authorization for KidneyIntelX.dkd to Assess Risk of Decline in Kidney Function in Adults with Type 2 Diabetes and Early-Stage Kidney Disease

©Waldenmarus/Adobe Stock FDA Awards de novo Marketing Authorization for KidneyIntelX.dkd to Assess Risk of Decline in Kidney Function in Adults with Type 2 Diabetes and Early-Stage Kidney Disease
©Waldenmarus/Adobe Stock

The KidneyIntelX.dkd prognostic testing platform for early-stage chronic diabetic kidney disease (DKD) on Thursday was granted do novo marketing authorization from the US Food and Drug Administration (FDA). The announcement was made by Renalytix plc.1

The first-in-class evaluation tool uses an artificial intelligence-enabled algorithm that combines data on blood-based biomarkers with clinical variables to guide assessment of and care management for adults with type 2 diabetes (T2D) and early stage DKD. Approximately 14 million people in the US are eligible for the test, according to the Renalytix announcement.

“Meeting the rigorous safety, clinical and analytical validation, and scientific data requirements of an FDA review, from Breakthrough Device designation to De Novo marketing authorization, is a landmark event for health care providers and patients with diabetic kidney disease,” said Renalytix CEO James McCullough. “With this approval a new class, Prognostic Test for Assessment of Chronic Kidney Disease Progression, has been established by the FDA, providing a roadmap for future expansion of KidneyIntelX into new indications and products.”

KidneyIntelX.dkd accurately stratifies a patient’s risk for progression of kidney disease within 5 years as low, intermediate, or high and is specific in early-stage disease. The comprehensive information on level of risk is independent of current standard of care measures.

Referred to as a “silent killer,” CKD is frequently asymptomatic even at advanced stages, making early detection and treatment pivotal. DKD is the leading cause of end stage kidney disease in the US and is now responsible for more deaths than either breast or prostate cancer, according to the statement.1

Since the platform was introduced as a Laboratory Developed Test (LDT), KidneyIntelX results have been reported on approximately 10 000 patients in the United States and there has been broad insurance payment including from Medicare and many private payers. Authorization by the FDA, Renalytix believes, will lead to more widespread adoption of the test; inform clinical guidelines; help expand insurance coverage; and facilitate additional international regulatory approvals.

The name KidneyIntelX.dkd is used to differentiate tests to be provided under the de novo marketing authorization by the FDA from those provided under the KidneyIntelX name as a LDT.

The KidneyIntelX platform is based on technology developed at the Icahn School of Medicine at Mount Sinai in New York, NY, and licensed to Renalytix.

Now viewed as a global public health epidemic, kidney disease affects more than 850 million people.2 In the US, the Centers for Disease Control and Prevention estimates that 15% of adults currently have CKD, with diabetes being a leading cause, responsible for 44% of new cases.3

1. FDA grants de novo marketing authorization for KidneyIntelX.dkd to assess risk of progressive kidney function decline in adults with diabetes and early stage kidney disease. News release. Renalytix. June 29, 2023. Accessed on June 30, 2023.
2. More than 850 million worldwide have some form of kidney disease: help raise awareness. New release. International Society of Nephrology. November 27, 2022. Accessed June 30, 2023.
3. Chronic kidney disease. Centers for Disease Control and Prevention. Accessed June 30, 2023. https://www.cdc.gov/kidneydisease/basics.html

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