LONDON and SALT LAKE CITY, March 14, 2024 (GLOBE
NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) (Renalytix)
announces that the KidneyIntelX In-Vitro Diagnostic test
has been included in the final KDIGO (Kidney Disease Improving
Global Outcomes) 2024 Clinical Practice Guideline for the
Evaluation and Management of Chronic Kidney Disease (CKD),
published on March 13, 2024. In the release of the new guideline,
timed to coincide with World Kidney Day on March 14, the KDIGO
committee highlighted the role of risk prediction in guiding care
for patients. In this context, KidneyIntelX is recommended for use
as an externally validated tool for predicting disease progression
in people with CKD stages G1-G3.
The Guideline Work Group recognized that the
progression of CKD can occur at all stages, and that in earlier
stages of disease (G1–G3), understanding the risk of 40% decline in
kidney function over a short term 5 years, as per the indicated use
of KidneyIntelX, is important for guiding early intervention,
particularly in people at intermediate or high risk for
progression. Renalytix received FDA de-novo marketing authorization
for kidneyintelX.dkd in June 2023 for use in assessment of the risk
of progressive decline in kidney function in patients with CKD
stages G1-G3 and Type 2 Diabetes.
Subsequent to the release of the draft content
of this updated guideline in July 2023, further evidence has been
published from clinical utility and outcomes studies with a current
enrollment of more than 9,000 patients with Type 2 Diabetes and CKD
G1-G3. In January 2024, published outcomes data from an analysis of
more than 2,500 patients with one year of follow-up demonstrated
that providing clinicians access to KidneyIntelX risk assessment to
inform care was associated with clinical actions that resulted in
sustained reduction in eGFR decline, improved diabetes management
and improved cardiovascular health.
In the KDIGO announcement of the
publication of the 2024 CKD guideline, Adeera Levin MD, one of the
Guideline Committee Co-Chairs said, “Recent
advancements in GFR evaluation, risk prediction, and the arrival of
novel treatments are poised to enhance CKD prognosis and
management. We also hope the guideline’s emphasis on
multidisciplinary teamwork, patient engagement, and a holistic,
evidence-based approach to care will help catalyze positive change,
resulting in more coordinated CKD care management worldwide. By
integrating the latest evidence and expert consensus, we aim to
empower healthcare professionals, and patients with actionable
recommendations to optimize patient outcomes and enhance quality of
life.”
Commenting on the guideline release
Michael J. Donovan, PhD, MD, Chief Medical Officer at
Renalytix stated, “Patients with
type 2 diabetes and CKD are benefitting from the evidence gathered
from a number of recent clinical trials and access to accurate risk
assessment to inform care in a significant and growing healthcare
challenge in the United States and globally. Renalytix welcomes
these new updates from KDIGO which provide for clear and timely
treatment strategies for health care professionals and we look
forward to continuing to release evidence to highlight the role
that KidneyIntelX is playing achieving the goal of optimizing
patients’ outcomes and enhancing quality of life.”
For further information, please
contact:
Renalytix plc |
www.renalytix.com |
James McCullough,
CEO |
Via Walbrook PR |
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|
Stifel
(Nominated Adviser, Joint Broker) |
Tel: 020 7710 7600 |
Alex Price / Nicholas
Moore / Nick Harland / Samira Essebiyea |
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|
Investec Bank
plc (Joint Broker) |
Tel: 020 7597 4000 |
Gary Clarence /
Shalin Bhamra |
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Walbrook PR
Limited |
Tel: 020 7933 8780 or
renalytix@walbrookpr.com |
Paul McManus / Alice
Woodings |
Mob: 07980 541 893 / 07407 804 654 |
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CapComm
Partners |
|
Peter DeNardo |
Tel: 415-389-6400 or investors@renalytix.com |
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About Chronic Kidney
Disease
Kidney disease is now recognized as a public health epidemic
affecting over 850 million people globally. The Centers for Disease
Control and Prevention (CDC) estimates that 15% of US adults, more
than 38 million people, currently have chronic kidney disease
(CKD). Diabetes is the leading cause of kidney failure, accounting
for 44% of new cases. Further, the CDC reports that 9 out of 10
adults with CKD do not know they have it and one out of two people
with very low kidney function who are not on dialysis do not know
they have CKD.1 Kidney disease is referred to as a
“silent killer” because it often has no symptoms and can go
undetected until a very advanced stage. Each year, kidney disease
kills more people than breast and prostate cancer. Every day, 13
patients in the United States die while waiting for a kidney
transplant.
About Type 2 Diabetes
More than 37 million Americans have diabetes (about 1 in 10), and
approximately 90-95% of them have type 2 diabetes. Type 2 diabetes
most often develops in people over age 45, but more and more
children, teens, and young adults are also developing the
disease2. Type 2 diabetes symptoms often develop over
several years and approximately 23% of adults with type 2 diabetes
are undiagnosed3. Type 2 diabetes affects many major
organs, including the heart, blood vessels, nerves, eyes and
kidneys. Diabetic kidney disease develops in 30-50% of type 2
diabetes patients4.
About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) is an
in-vitro diagnostics and laboratory services company that is the
global founder and leader in the new field of bioprognosis™ for
kidney health. The leadership team, with a combined 200+ years of
healthcare and in-vitro diagnostic experience, has designed its
KidneyIntelX laboratory developed test to enable risk assessment
for rapid progressive decline in kidney function in adult patients
with T2D and early CKD (stages 1-3). We believe that by
understanding how disease will progress, patients and providers can
take action early to improve outcomes and reduce overall health
system costs. For more information, visit www.renalytix.com.
About the Kidney Disease: Improving
Global Outcomes (KDIGO) 2024 Clinical Practice Guideline
for
the Evaluation and Management of Chronic Kidney Disease
(CKD)
The Kidney Disease: Improving Global Outcomes (KDIGO) 2024 Clinical
Practice Guideline for the Evaluation and Management of Chronic
Kidney Disease (CKD) is an update to the KDIGO 2012 guideline on
the topic. The aim is to assist clinicians caring for people with
CKD, both adults and children. People receiving dialysis and kidney
transplant recipients are not the focus of this guideline. The
scope includes chapters dedicated to the evaluation of CKD, risk
assessment in people with CKD, management to delay CKD progression
and manage its complications, medical management and drug
stewardship in CKD, and optimal models of CKD care. In addition,
this guideline includes a comprehensive introduction from the
guideline Co-Chairs, a patient foreword, a discussion of special
population considerations, a presentation of the relative and
absolute risks associated with specific outcomes from the CKD
Prognosis Consortium (CKDPC), and an extensive section dedicated to
research recommendations based on the current gaps in evidence. The
goal of the guideline is to generate a useful resource for
clinicians and patients by providing actionable recommendations
based on a rigorous formal evidence review, practice points that
serve to direct clinical care or activities for which a systematic
review was not conducted, and useful infographics. The guideline
targets a broad audience of healthcare providers involved in the
care of people with CKD as well as people with CKD themselves while
being mindful of implications for policy and payment. Development
of this guideline update followed an explicit process of evidence
review and appraisal. Treatment approaches and guideline
recommendations are based on systematic reviews of relevant
studies, and appraisal of the certainty of the evidence and the
strength of recommendations followed the “Grading of
Recommendations Assessment, Development, and Evaluation” (GRADE)
approach. Limitations of the evidence are discussed, with areas of
future research also presented.
Sources |
1 |
https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/ |
2 |
https://www.cdc.gov/diabetes/basics/type2.html |
3 |
https://www.cdc.gov/diabetes/data/statistics-report/index.html |
4 |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/ |
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Forward Looking Statements
Statements contained in this announcement regarding matters that
are not historical facts are “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended. Examples of these forward-looking statements
include statements concerning: the ability of KidneyIntelX to
predict disease progression in people with CKD stages G1-G3 and
guide early intervention; the ability of KidneyIntelX risk
assessment to inform care resulting in sustained reduction in eGFR
decline, improved diabetes management and improved cardiovascular
health; and the ability of the KDIGO 2024 Clinical Guideline’s
emphasis on multidisciplinary teamwork, patient engagement, and a
holistic, evidence-based approach to care to help catalyze positive
change, resulting in more coordinated CKD care management
worldwide. Words such as “anticipates,” “believes,” “estimates,”
“expects,” “intends,” “plans,” “seeks,” and similar expressions are
intended to identify forward-looking statements. We may not
actually achieve the plans and objectives disclosed in the
forward-looking statements, and you should not place undue reliance
on our forward-looking statements. Any forward-looking statements
are based on management’s current views and assumptions and involve
risks and uncertainties that could cause actual results,
performance, or events to differ materially from those expressed or
implied in such statements. These risks and uncertainties include,
among others: that KidneyIntelX and kidneyintelX.dkd are based on
novel artificial intelligence technologies that are rapidly
evolving and potential acceptance, utility and clinical practice
remains uncertain; we have only recently commercially launched
KidneyIntelX; and risks relating to the impact on our business of
the COVID-19 pandemic or similar public health crises. These and
other risks are described more fully in our filings with the
Securities and Exchange Commission (SEC), including our most recent
Quarterly Report on Form 10-Q and the “Risk Factors” section of our
Annual Report on Form 10-K filed with the SEC on September 28,
2023, and other filings we make with the SEC from time to time. All
information in this press release is as of the date of the release,
and we undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, or otherwise, except as required by law.
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