New published data demonstrates KidneyIntelX™ has broad implications for winning war on chronic kidney disease
10 January 2024 - 11:00PM
Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces publication of
Real World Evidence (“RWE”) after 12 months of follow-up
in 2,569 patients with Type 2 diabetes and diabetic kidney
disease (“DKD”) at a major U.S. health system in Primary Care and
Community Health. Results in the diverse cohort, including 27%
black patients, demonstrate that electronic health record
deployment of KidneyIntelX in vitro prognostic testing was
associated with clinical actions that led to a significant slowing
of chronic kidney disease progression and improved Type 2 diabetes
control most notably in the highest risk patients.
Improved kidney health was evidenced by
reduction in the rate of kidney function decline (eGFR slope) and
diabetes control was evidenced by improved A1C levels. KidneyIntelX
testing achieved scale through electronic health record
integration, deploying directly to large treating groups of primary
care physicians. These improvements, coupled with increase in
percentage of KidneyIntelX high-risk patients achieving blood
pressure control, have been shown to be associated with
improvements in cardiovascular health and outcomes in CKD.
KidneyIntelX has received broad insurance
payment coverage including through Medicare, Medicaid, and Blue
Cross Blue Shield programs. The Food and Drug Administration (FDA)
issued a de Novo Marketing Authorization of the kidneyIntelX.dkd
version of the test in June 2023 with an indicated use addressable
market of approximately 14 million patients with adult diabetes and
kidney disease.
“The demonstrated benefits of KidneyIntelX early
risk assessment at one year are significant and go to the core of
chronic disease preventative medicine. This real-world data
highlights the critical importance of early preventative care and
the ability to better control cost and outcomes through efficient
electronic deployment of KidneyIntelX bioprognosis,” said
Michael J. Donovan, PhD, MD, Chief Medical Officer at
Renalytix. “We look forward to continuing published data
releases in coming months in order to support our belief that
KidneyIntelX provides actionable information leading to
preventative care and improving healthcare outcomes.”
“This published real world evidence puts
KidneyIntelX at the intersection of multiple established diabetes,
kidney and cardiovascular care guidelines. This data is
compelling and shows the importance of adopting KidneyIntelX across
primary care networks to help control these unsustainable chronic
diseases that unnecessarily effect millions of patients,”
said James McCullough CEO of
Renalytix.
The study population includes representation of
a number of high-risk factors for disease progression including (a)
patient median baseline age of 68 years (b) 27% Black, (c) median
BMI of 30 (d) evidence of hypertension in 89% of subject, and (e)
9% with stage A-D, American Heart Association functional classified
heart failure. Analysis of treating physicians shows that the
majority of patients were being treated by their primary care
physician.
The RWE study results demonstrated that patients
with Type 2 Diabetes and Stage 1-3 CKD and a high-risk KidneyIntelX
score received higher frequency of clinical management visits,
improved utilization of guideline-recommended medications, and
appropriate specialist referral or consultation for disease
management compared to those who were identified as low or
intermediate risk patients.
For further information, please
contact:
Renalytix plc |
www.renalytix.com |
James McCullough,
CEO |
Via Walbrook PR |
|
|
Stifel
(Nominated Adviser, Joint Broker) |
Tel: 020 7710 7600 |
Alex Price / Nicholas
Moore / Nick Harland / Samira Essebiyea |
|
|
|
Investec Bank
plc (Joint Broker) |
Tel: 020 7597 4000 |
Gary Clarence /
Shalin Bhamra |
|
|
|
Walbrook PR
Limited |
Tel: 020 7933 8780 or
renalytix@walbrookpr.com |
Paul McManus / Alice
Woodings |
Mob: 07980 541 893 / 07407 804 654 |
|
|
CapComm
Partners |
|
Peter DeNardo |
Tel: 415-389-6400 or investors@renalytix.com |
|
|
About Chronic Kidney
DiseaseKidney 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 DiabetesMore 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 RenalytixRenalytix
(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.
Sources1 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.html3
https://www.cdc.gov/diabetes/data/statistics-report/index.html4
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/
Forward Looking
StatementsStatements 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
commercial prospects of KidneyIntelX and kidneyintelX.dkd,
including whether KidneyIntelX and kidneyintelX.dkd will be
successfully adopted by physicians, inform clinical guidelines,
lead to clinical actions that improve patient outcomes, achieve
expanded insurance coverage and be successfully distributed and
marketed, the potential for KidneyIntelX and kidneyintelX.dkd to be
expanded and approved for additional indications and in additional
jurisdictions, our expectations regarding the impact and benefits
of the CMS action on the value or pricing of KidneyIntelX, our
expectations with respect to reimbursement decisions, our
intellectual property position, our competitive position and the
ability of KidneyIntelX and kidneyintelX.dkd to curtail costs of
chronic and end-stage kidney disease, optimize care delivery and
improve patient outcomes. 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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