Collaboration with Quest Diagnostics
Renalytix plc has entered into a multi-year agreement with Quest Diagnostics to expand the availability of its kidneyintelX.dkd blood testing across the United States, aiming to provide earlier risk prediction for progressive kidney function decline in an estimated 15 million U.S. adult patients with type 2 diabetes and early-stage chronic kidney disease. This collaboration will allow physicians to order the FDA-authorized and Medicare-reimbursed test through Quest's extensive network, which serves approximately half of U.S. physicians and hospitals, with availability expected in the first quarter of 2027. Quest Diagnostics also holds an option to in-license kidneyintelX.dkd upon achievement of certain commercialization milestones.
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LONDON and NEW YORK, 1 September, 2026 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a precision medicine diagnostics company focused on kidney disease, announces that it has signed a multi-year agreement (the "Agreement") with Quest Diagnostics, a leading provider of diagnostic information services ("Quest"), to make kidneyintelX.dkd blood testing available to physicians and patients served by Quest in the United States.
The Agreement covers the establishment of a national programme to enable U.S. healthcare providers the ability to access and order the Renalytix kidneyintelX.dkd test through Quest's connectivity. kidneyintelX.dkd is the first and only test to receive FDA authorization and Medicare reimbursement for the prediction of risk of progressive decline in kidney function in the estimated 15 million U.S. adult patients with type 2 diabetes and early-stage chronic kidney disease. The blood-based kidneyintelX.dkd test enables earlier, guideline-directed care before patients reach high-cost clinical milestones, such as dialysis or transplantation, which is important as Medicare spending on chronic kidney disease now exceeds $130 billion annually.
Quest serves approximately half the physicians and hospitals in the U.S. Under the Agreement, physicians will be able to directly order kidneyintelX.dkd through their existing Quest account and electronic health record. Patients will also be able to use Quest's 2,000 patient service centers and 6,000 in-office phlebotomists for blood draws in the United States. Renalytix will perform and bill for its proprietary kidneyintelX.dkd test from its lab in New York. kidneyintelX.dkd is expected to be available for physician ordering through Quest's connectivity services in the first quarter of 2027.
Pursuant to the Agreement, Quest has the option to in-license kidneyintelX.dkd when certain commercialization milestones are achieved.
Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in vitro diagnostics company dedicated to optimizing kidney disease management through precision-based care intervention. It's KidneyIntelX™ technology and data-driven insights help clinical teams understand patient level of risk for progressive decline in kidney function in the earliest stages of diabetic kidney disease. This enables clinicians to focus resources and guideline-recommended treatment, providing the best chance for improving kidney and overall renal-cardio-metabolic outcomes.
Renalytix has been granted FDA authorization and Medicare reimbursement for kidneyintelX.dkd which is offered commercially throughout the United States. For more information about the kidneyintelX.dkd test, visit www.kidneyintelx.com.
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