Renalytix Partners with Tempus AI to Expand Access to FDA-Approved Kidney Disease Risk Test
Key Insights
Renalytix (search) has signed a collaboration agreement with Tempus AI to make its FDA-approved kidneyintelX.dkd (search) test more widely available within Tempus' US healthcare network.
The test targets nearly 15 million Americans with type 2 diabetes and chronic kidney disease, providing risk assessment for progressive kidney function decline.
kidneyintelX.dkd (search) becomes the first chronic kidney disease test in Tempus' portfolio and has Medicare (search) reimbursement at $950 per reportable result.
Renalytix (search) plc has announced a definitive collaboration agreement with Tempus AI, Inc. to accelerate the adoption of its kidneyintelX.dkd (search) test, the only FDA-approved and Medicare (search) reimbursed prognostic test for chronic kidney disease risk assessment. The partnership will make the diagnostic tool more widely available within Tempus' US network of healthcare institutions, targeting eligible patients with type 2 diabetes and chronic kidney disease.
Addressing a Massive Patient Population
The collaboration targets nearly 15 million individuals in the US who have type 2 diabetes with chronic kidney disease. Renalytix (search)'s kidneyintelX.dkd (search) will be the first test offered in Tempus' portfolio in the chronic kidney disease category, indicated for use as an aid in predicting level of risk (high, moderate, low) for progressive decline in kidney function in type 2 diabetes patients with diagnosed chronic kidney disease stages 1-3b.
"The unique Tempus platform, with its broad clinical reach, will allow us to significantly expand patient and clinician access to advanced kidneyintelX.dkd (search) precision medicine testing in one of the largest and costliest chronic disease conditions today," said James McCullough, CEO of Renalytix (search). "Further, we expect our partnership to be instrumental in driving therapeutic and diagnostic innovation through multi-modal data accumulation and analysis in patients in the cardiovascular, renal and metabolic space."
Strategic Implementation and Clinical Workflow Integration
Under the agreement, Tempus and Renalytix (search) will collaborate with US health systems to make testing more available for providers to order within existing clinical workflows. The kidneyintelX.dkd (search) tests will be processed in a Renalytix laboratory with customized patient results reported electronically to the ordering clinician and patient portal, where applicable.
Ryan Fukushima, Tempus Chief Operating Officer, commented: "We share Renalytix (search)'s mission of developing AI-enabled diagnostics designed to support clinicians in surfacing new insights that can inform patient care. This collaboration expands our reach into the diabetes and chronic kidney disease space, and we look forward to bringing our technology to these patients."
Proven Clinical Impact and Reimbursement
The test's insights allow for timely changes in patient management, which can help providers mitigate progressive decline in kidney function and improve key quality metrics in diabetes and kidney care. kidneyintelX.dkd (search) now has full reimbursement established by Medicare (search), the largest insurance payer in the United States, at $950 per reportable result.
Over 15,000 patients have been tested by kidneyintelX.dkd (search), producing a substantial body of real-world performance data. In patient populations where kidneyintelX.dkd has been deployed, a demonstrated and significant increase in diagnosis, prognosis, and treatment rates have been recorded. The test is also recommended for use in the international chronic kidney disease clinical guidelines (KDIGO).
Addressing a Global Health Crisis
Chronic kidney disease represents a worldwide public health crisis impacting 850 million individuals globally. According to the National Kidney Foundation, it is estimated to impact more than 35 million adults in the United States, with 90% of those affected unaware they have the condition. Medicare (search) spends over $130 billion annually to care for those with kidney disease and kidney failure.
Unrecognized and uncontrolled kidney disease remains one of the largest barriers to controlling cost and suffering in the United States and the United Kingdom's medical system, affecting over 14 million and 8 million people, respectively. After five years of development and clinical validation, kidneyintelX.dkd (search) is positioned as the only FDA-approved and Medicare (search) reimbursed prognostic tool capable of understanding a patient's risk with kidney disease early where treatment has maximal effect.