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RNS Number : 0899W Renalytix PLC 06 February 2025
Renalytix plc
("Renalytix" or the "Company")
kidneyIntelX.dkd Published in Journal of the American Society of Nephrology
LONDON and NEW YORK, 6 February 2025 - Renalytix plc (LSE: RENX) (OTCQB:
RNLXY), which is commercialising kidneyintelX.dkd, the only FDA-approved and
Medicare reimbursed prognostic test to support early-stage risk assessment for
chronic kidney disease, notes the publication of the paper kidneyintelX.dkd:
An Innovation in Precision Medicine for Diabetic Kidney Disease
(https://journals.lww.com/jasn/citation/9900/kidneyintelx_dkd__an_innovation_in_precision.542.aspx)
(https://journals.lww.com/jasn/citation/9900/kidneyintelx_dkd__an_innovation_in_precision.542.aspx)
in the Journal of the American Society of Nephrology (JASN), the leading
journal in the advancement of understanding and treatment of kidney
diseases.
The paper, published by invitation for dissemination of innovative
technologies, highlights kidneyintelX.dkd as a critical risk assessment tool
to enable a personalised approach to treatment and identification of those who
would benefit most from multifaceted therapy to slow the progression of DKD.
The publication also discusses the inclusion of kidneyintelX.dkd in the
recently published KDIGO guidelines, which recommends "risk assessment to
assist with delivery of personalized care for people with CKD":
"With multiple new drug classes now available for DKD management in addition
to baseline RAAS inhibition, precision medicine solutions such as
kidneyintelX.dkd can change the current paradigm to a more individualized
approach. Some experts advocate an 'accelerated risk-based approach' in which
prioritization for 'quadruple therapy' is reserved for those at highest
absolute risk for progression, given costs and potential adverse events."
This is particularly relevant with the recent regulatory approvals of
Ozempic® for treatment of DKD, further fuelling the need for an accelerated
risk-based approach targeting those at the highest risk of progression,
thereby ensuring the best possible health outcomes and avoiding unnecessary,
expensive treatments for those at lower risk.
Fergus Fleming, Chief Technology Officer of Renalytix, commented:
"The age of precision medicine in chronic disease is just beginning and will
be central to preventative care, improved patient outcomes, and control of
spiralling healthcare costs. We welcome the publication of the
kidneyintelX.dkd innovation in this prestigious journal which will help to
better inform the nephrology and wider healthcare community on the power and
utility of biomarker -based early risk assessment with kidneyintelX.dkd.
"With multiple new drugs coming into wider use in the clinic, including Novo
Nordisk's achievement this month securing approval for Ozempic for the
treatment of DKD, the ability to accurately understand a patient's disease
risk is paramount. We have invested over six years developing kidneyintelX.dkd
to deliver an accurate, FDA regulated, Medicare reimbursed prognosis directly
to physicians charged with making timely therapeutic decisions."
The full text of the publication will be available here in due course:
https://www.kidneyintelx.com/evidence/
(https://www.kidneyintelx.com/evidence/)
For further information, please contact:
Renalytix plc www.renalytix.com (http://www.renalytix.com)
James McCullough, CEO Via Walbrook PR
Stifel (Nominated Adviser and Joint Broker) Tel: 020 7710 7600
Nicholas Moore / Nick Harland / Ben Good
Oberon Capital (Joint Broker) Tel: 020 3179 5300
Mike Seabrook / Nick Lovering
Walbrook PR Limited Tel: 020 7933 8780 or renalytix@walbrookpr.com
Paul McManus / Alice Woodings Mob: 07980 541 893 / 07407 804 654
About Renalytix (www.renalytix.com (http://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 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 is the only FDA-approved and Medicare reimbursed prognostic
tool capable of understanding a patient's risk with 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 10,000 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).
Disclosure: KidneyIntelX is based on innovative technology developed by Mount
Sinai faculty and licensed to Renalytix. Mount Sinai faculty-inventors and
Mount Sinai have equity ownership in Renalytix.
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