US Kidney Care National Plan
Summary by AI BETAClose X
Renalytix plc
(“Renalytix” or the “Company”)
US Kidney Care National Plan reinforces kidneyintelX.dkd opportunity
HHS prioritizes early detection, risk-based prevention and payment for slowing kidney disease progression –
the clinical need kidneyintelX.dkd is built to address
LONDON and NEW YORK, 22 October 2026 – Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a precision medicine diagnostics company focused on kidney disease, notes the publication on October 20, 2026, of the Kidney Care National Plan (the “Plan”) by the US Department of Health and Human Services (“HHS”). The Plan marks a shift in US policy from managing kidney failure towards preventing it. The Plan’s priorities align directly with kidneyintelX.dkd, Renalytix’s FDA-authorized and Medicare-reimbursed prognostic blood test for adults with type 2 diabetes and early-stage chronic kidney disease (“CKD”).
The scale of the problem identified by HHS
According to the Plan, an estimated 37 million American adults have CKD, and around 87 per cent of them do not know they have it. In 2023, Original Medicare spent more than $141 billion on beneficiaries with CKD who had not yet progressed to kidney failure, in addition to approximately $24.4 billion in Original Medicare and $27.7 billion in Medicare Advantage spending on patients with end-stage renal disease (“ESRD”). HHS notes that this federal obligation “is set years before it is paid, when the disease is progressing quietly and often undetected.”
Key themes of the Plan and their relevance to Renalytix
- Prevention is now the stated federal priority. HHS states that “the highest priorities in addressing earlier-stage CKD are to slow the progression to kidney failure and to encourage more innovation across the full continuum of kidney care.”
- kidneyintelX.dkd’s patient population is identified as the problem to solve. The Plan states that “a patient with early-stage CKD and uncontrolled diabetes represents a foreseeable future ESRD case.” These are the patients, an estimated 15 million US adults with type 2 diabetes and early-stage CKD, for whom kidneyintelX.dkd is FDA-authorized to assess the risk of progressive decline in kidney function.
- Expanding early detection. HHS calls for early detection to be expanded “so that at-risk patients are identified early enough for effective interventions to make a meaningful difference on disease progression.” kidneyintelX.dkd goes beyond detecting CKD to identifying which patients are most likely to progress.
- Implementing precision-based care. The Plan highlights that key therapeutics, SGLT2 inhibitors and GLP-1 receptor agonists, both approved by the FDA, “require expensive upfront costs,” and acknowledges that we don’t always know “who should receive which therapy, or which combination, and when.” It calls for “a precision medicine approach” to “match patients with the right treatment at the right time.” kidneyintelX.dkd helps clinicians do just that, by focusing guideline-directed care on the patients at greatest risk of progression.
Commenting, James McCullough, CEO of Renalytix, said:
“This Plan is one of the clearest signals yet from the US Government that the future of kidney care is prevention, and that prevention depends on knowing which patients are heading towards kidney failure while there is still time to change their course. That is precisely the question kidneyintelX.dkd was built to answer.
“HHS has described the patient with diabetes and early-stage kidney disease as a ‘foreseeable future ESRD case’. We already have an FDA-authorized, Medicare-reimbursed test that identifies which of those patients are at highest risk, and in early 2027, physicians across the United States will be able to order it through Quest Diagnostics.
“The Plan makes clear that payment is moving towards rewarding providers for slowing disease rather than treating its consequences, and that costly new therapies must reach the right patients at the right time. Neither can happen without reliable risk stratification. Renalytix has the regulatory authorization, reimbursement, clinical evidence and national distribution in place to meet that need, and we intend to lead this market.”
Last month, Renalytix signed a multi-year agreement with Quest Diagnostics (“Quest”), a leading provider of diagnostic information services, to establish a national program giving US healthcare providers access to kidneyintelX.dkd through Quest’s connectivity. Physicians will be able to order kidneyintelX.dkd through their existing Quest account and electronic health record, and patients will be able to use Quest’s 2,000 patient service centers and 6,000 in-office phlebotomists for blood draws. Renalytix will perform and bill for the test at its laboratory in New York. kidneyintelX.dkd is expected to be available for ordering through Quest in early 2027.
kidneyintelX.dkd is the first and only test to receive FDA authorization and Medicare reimbursement for assessing the risk of progressive decline in kidney function in adults with type 2 diabetes and early-stage CKD. By enabling earlier, guideline-directed care, it directly supports the Plan’s aim of slowing progression before patients reach high-cost outcomes such as dialysis or transplantation.
A Press Release from the US Department of Health and Human Services is available here:
HHS Launches Landmark National Plan to Transform Kidney Care in America | HHS.gov
A PDF of the full Kidney Care National Plan is available here:
For further information, please contact:
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Renalytix plc |
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James McCullough, CEO |
Via Walbrook PR | |
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SP Angel Corporate Finance LLP (Nominated Adviser, Joint Broker) |
Tel: +44 (0)20 3470 0470 | |
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David Hignell / Jen Clarke (Corporate Finance) |
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Vadim Alexandre (Corporate Broking) |
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Oberon Capital (Joint Broker) |
Tel: +44 (0)20 3179 5300 | |
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Mike Seabrook / Nick Lovering |
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Walbrook PR Limited |
Tel: +44 (0)20 7933 8780 or renalytix@walbrookpr.com | |
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Paul McManus / Alice Woodings |
Mob: +44 (0)7980 541 893 / +44 (0)7407 804 654 | |
About kidneyintelX.dkd and RenalytixTM (www.kidneyintelx.com and www.renalytix.com)
RenalytixTM (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in vitro diagnostics company dedicated to optimizing kidney disease management through precision-based care intervention. Its 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.
Unrecognized and uncontrolled diabetic kidney disease remains one of the largest barriers to reducing suffering and controlling cost in the United States and United Kingdom medical systems, affecting approximately 15 million and 8 million people, respectively.
RenalytixTM 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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