REG - Renalytix PLC - Key milestones achieved for kidneyintelX.dkd

RenalytixAnnouncement

22/04/2026 07:00

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RNS Number : 3893B  Renalytix PLC  22 April 2026

 

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Renalytix plc

("Renalytix" or the "Company")

 

Key regulatory milestones achieved in support of scaling of kidneyintelX.dkd

 

·      New laboratory enables 3.5x increase in testing volumes at
reduced operating cost

·      Submission of Technical Review for the CE marking of
kidneyintelX.dkd completed

 

LONDON and NEW YORK, 22 April 2026 - Renalytix plc (LSE: RENX) (OTCQB:
RNLXY), a precision medicine diagnostics company, with kidneyintelX.dkd, the
only FDA-approved and Medicare reimbursed prognostic test to support
early-stage risk assessment in chronic kidney disease, announces the
successful completion of the transfer of laboratory operations to a state of
the art facility in New York.

 

The new facility significantly enhances operational capability, increasing
testing capacity by more than 3.5x and providing a scalable infrastructure to
support growth to in excess of 100,000 tests per annum. This expanded capacity
positions the Company to efficiently meet growing demand and support broader
commercial adoption. Execution of the transfer included comprehensive
analytical validation of the kidneyintelX.dkd assay and regulatory inspection
of the facility by the New York State Department of Health.

 

The transition also delivers immediate cost efficiencies, materially reducing
the Company's fixed cost base in the near term, with the potential to generate
substantial longer-term value with expected cost savings of over $2.6 million
on a net present value basis over five years. The reduced cost base is
expected to deliver immediate gross margin gains and drive meaningful
operating leverage as testing volumes scale.

 

Additionally, the Company announces that it has completed, to schedule, the
submission for CE marking of the technical file for kidneyintelX.dkd.  As
previously announced
(https://www.londonstockexchange.com/news-article/RENX/ce-mark-application-submission/17256902)
, achievement of CE marking is a core strategy to enable use of
kidneyintelX.dkd in global pharma clinical trials while at the same time,
enabling commercialisation of kidneyintelX.dkd in certain European
markets. The Company expects to finalise the CE marking process in Q3 2026
with initial testing of patients and data generation from the Steno Diabetes
Center expected in Q4 2026 and expanding to services revenue generating
testing at multiple sites in 2027.

 

For further information, please contact:

 

 Renalytix plc                                    www.renalytix.com
 James McCullough, CEO                            Via Walbrook PR

 SP Angel Corporate Finance LLP (Nominated Adviser, Joint Broker)                    Tel: +44 (0)20 3470 0470
 David Hignell / Jen Clarke (Corporate Finance)
 Vadim Alexandre (Corporate Broking)

 Oberon Capital (Joint Broker)                    Tel: +44 (0)20 3179 5300
 Mike Seabrook / Nick Lovering

 Walbrook PR Limited                              Tel: +44 (0)20 7933 8780 or renalytix@walbrookpr.com
 Paul McManus / Alice Woodings                    Mob: +44 (0)7980 541 893 / +44 (0)7407 804 654

About Renalytix ( www.renalytix.com )

 

Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in
vitro diagnostics company, focused on optimizing clinical management of
kidney disease to drive improved patient outcomes. Renalytix has received FDA
approval and Medicare reimbursement for kidneyintelX.dkd which is now
offered commercially in the United States.

Unrecognized and uncontrolled diabetic 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 approximately 15 million and 8
million people, respectively. After five years of development and clinical
validation, kidneyintelX.dkd is the only FDA-approved and
Medicare-reimbursed prognostic tool capable of understanding a patient's risk
with diabetic kidney disease early where treatment has maximal
effect. kidneyintelX.dkd is now being deployed across large physician group
practices and health systems in select regions of the United States.

 

The over 15,000 patients that have been tested by kidneyintelX.dkd have
produced 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. kidneyintelX.dkd now has full reimbursement established by
Medicare, the largest insurance payer in the United States, at $950 per
reportable result. kidneyintelX.dkd is also recommended for use in the
international chronic kidney disease clinical guidelines (KDIGO).

 

KidneyIntelX is based on technology developed by Mount Sinai faculty and
licensed to Renalytix AI, Inc. Mount Sinai faculty members are co-founders and
equity owners in the Company. In addition, the Icahn School of Medicine at
Mount Sinai has equity ownership in Renalytix. For information about the
kidneyintelX.dkd test, visit kidneyintelx.com.

 

LEI - 213800NTOH3FK3WER551

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