Deployment of Renalytix’s (NASDAQ: RNLX) (LSE: RENX) KidneyIntelXTM
bioprognosticTM testing in 1,112 adult diabetic kidney disease
(DKD) patients at Mount Sinai Health System demonstrated utility in
driving guideline appropriate use of therapies, including SGLT-2
inhibitors and RAAS inhibitor use, and timely consultation to
specialists in high-risk patients. The Mount Sinai clinical utility
data was presented as a late-breaking ePoster session on June 5th
at the American Diabetes Association 82nd Scientific Sessions® in
New Orleans. In the study, more than half of KidneyIntelX
prognostic tests were ordered by primary care physicians, followed
by endocrinologists. Application of guideline-based care, including
therapeutics and appropriate specialist consultation, increased in
proportion to reported risk of rapid progressive decline in kidney
function (e.g., low, intermediate, or high risk).
“Before KidneyIntelX, we did not have a way to effectively
predict which patients with early stage DKD are at higher risk for
progressive loss of kidney function and kidney failure,” said Joji
Tokita, M.D., Clinical Director, Division of Nephrology, and
Associate Professor, Medicine (Nephrology), Icahn School of
Medicine at Mount Sinai. “Nearly 95 percent of patients with
chronic kidney disease are in stages 1 through 3, but its
progression is often asymptomatic until it progresses to end stages
and the damage is often irreversible. End-stage kidney disease
results not only in poor quality of life for patients, but
significant and costly care that can include cardiovascular
complications, increased hospitalizations, dialysis and transplant.
I’m encouraged to see the real-world application of KidneyIntelX by
my primary care colleagues, where we can follow guideline-based
care to reduce patient risk early and change the trajectory of
disease progression and costs.”
“Understanding the clinical utility of diagnostic tools like
KidneyIntelX in a real-world setting is critical to increasing
access and availability of our testing in the United States,” said
Tom McLain, President, Renalytix. “The findings from this clinical
utility study reinforce the growing body of evidence demonstrating
that KidneyIntelX can help to address significant unmet needs in
DKD. An easy to understand, actionable risk score and care path
allows primary care physicians to act early before health declines
and significant kidney damage can occur.”
The breakdown of risk in the real-world evidence (RWE)
population was similar to what was observed in peer-reviewed,
published KidneyIntelX clinical validation cohorts: High risk 13%
vs. 17%; intermediate 40% vs. 37%; and low risk 46% vs 46%. In the
1,112 patients tested, KidneyIntelX re-stratified patient’s risk
from standard kidney function metrics (eGFR and UACR) and
identified high risk adult patients with type 2 diabetes that were
in stages 1, 2, and 3 of chronic kidney disease (CKD). Most
importantly, the KidneyIntelX test helped physicians overcome the
inertia seen with novel therapeutics proven to slow CKD progression
and reduce associated patient cardiovascular event risk. As
compared to patients who scored low risk, there were increases in
use of anti-hypertensives, a 6-fold increase in the initiation of
guideline-recommended treatments (SGLT-2 inhibitors or GLP-1
receptor agonists), and a nearly 3-fold increase in referrals to
nephrologists, endocrinologists or dietitians. In the high-risk
patient category, 20% of patients were referred to a specialist.
Additionally, there was an increase in appropriate use of SGLT-2
inhibitor prescriptions by increased level of risk score.
“Even in my diabetes patients that are vigilant with their care,
KidneyIntelX has proven to be a valuable tool to understand their
risk of rapid kidney disease progression and take early action,”
said Aida Vega, M.D., Associate Professor of Medicine (General
Internal Medicine), Icahn Mount Sinai, and Director, Primary Care
Program, Mount Sinai Doctors Faculty Practice. “Informed decision
making and individualized care for CKD patients is vital in
preventing associated complications and progression to end stage
renal disease. The earlier we can understand the risk of rapid
progression of the disease, the sooner we can take action to
improve and preserve health for these patients.”
There are approximately 71,000 patients with type 2 diabetes and
chronic kidney disease in the Mount Sinai Health System across New
York City. Clinical utility study results are being prepared to be
published in a peer reviewed publication in 2022. The Mount Sinai
Health System is New York City’s largest academic medical system,
encompassing eight hospitals, a leading medical school, and a vast
network of ambulatory practices throughout the greater New York
region.
KidneyIntelX is available clinically as a laboratory developed
test. It has received Breakthrough Device Designation from the U.S.
Food and Drug Administration (FDA) and has been submitted to the
FDA for De Novo marketing authorization.
KidneyIntelX includes technology that was initially developed by
Mount Sinai faculty. This technology has been licensed by Mount
Sinai to Renalytix. Mount Sinai and a small number of Mount Sinai
faculty inventors have a financial interest in Renalytix. Mount
Sinai also has representation on the Renalytix Board of
Directors.
About Kidney DiseaseKidney disease is a public
health epidemic affecting over 850 million people globally.1 The
Centers for Disease Control and Prevention estimates that 15% of
U.S. adults, or over 37 million people2, have chronic kidney
disease (CKD). Nearly 95% of people with CKD are in early stages
1-33. Despite its magnitude, early-stage (1-3) CKD is
underdiagnosed and undertreated, largely because it’s asymptomatic
at this time in the disease. As many as 9 in 10 adults with CKD,
and 2 in 5 adults with severe CKD do not know they have the
condition.2
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
bioprognosisTM 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 with 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 KidneyIntelXTM
KidneyIntelXTM is a laboratory-developed test demonstrated to be a
reliable, bioprognosticTM methodology that yields a
simple-to-understand, custom risk score, enabling prediction of
which adult patients with T2D and early CKD (stages 1-3) are at
low, intermediate or high risk for rapid progressive decline in
kidney function. By combining information from KidneyIntelX with
newer cardio- and reno-protective therapies, doctors will have more
information in determining which patients are at higher versus
lower risk for rapid disease progression and may be able to more
appropriately target resources and guideline-recommended treatments
to advance kidney health. KidneyIntelX is supported by a growing
body of clinical, utility and health economic studies (including a
validation study of two large cohorts) and has a demonstrated a 72%
improvement in predicting those patients who are at high risk for
rapid progressive decline in kidney function versus the current
standard of care (eGFR and UACR). KidneyIntelX has also received
Breakthrough Device Designation from the U.S. Food and Drug
Administration and has submitted for De Novo marketing
authorization. To learn more about KidneyIntelX and review the
evidence, visit www.kidneyintelx.com.
About the Mount Sinai Health SystemThe Mount
Sinai Health System is New York City’s largest academic medical
system, encompassing eight hospitals, a leading medical school, and
a vast network of ambulatory practices throughout the greater New
York region. Mount Sinai is a national and international source of
unrivaled education, translational research and discovery, and
collaborative clinical leadership ensuring that we deliver the
highest quality care—from prevention to treatment of the most
serious and complex human diseases. The Health System includes more
than 7,200 physicians and features a robust and continually
expanding network of multispecialty services, including more than
400 ambulatory practice locations throughout the five boroughs of
New York City, Westchester, and Long Island. The Mount Sinai
Hospital is ranked No. 14 on U.S. News & World
Report’s “Honor Roll” of the Top 20 Best Hospitals in the
country and the Icahn School of Medicine as one of the Top 20 Best
Medical Schools in the country. Mount Sinai Health System hospitals
are consistently ranked regionally by specialty and our physicians
in the top 1% of all physicians nationally by U.S. News &
World Report.
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/kidneydisease/publications-resources/ckd-national-facts.html
3 https://www.cdc.gov/kidneydisease/basics.html
Forward Looking Statements
Statements contained in this press release 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 potential benefits, including
economic savings, of KidneyIntelX, the potential for KidneyIntelX
to receive regulatory approval from the FDA, the commercial
prospects of KidneyIntelX, if approved, including whether
KidneyIntelX will be successfully adopted by physicians and
distributed and marketed, our expectations regarding reimbursement
decisions and the ability of KidneyIntelX 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 is 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 the "Risk Factors" section of our
annual report on Form 20-F filed with the SEC on October 21, 2021,
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.
Media Contacts:United
States:Chloe BeaudoinRenalytix(207)
333-7947cbeaudoin@renalytix.com
Outside of the United States:Walbrook
PR LimitedPaul McManus / Lianne Applegarth / Alice
WoodingsTel: 020 7933 8780 or renalytix@walbrookpr.com Mob:
07980 541 893 / 07584 391 303 / 07407 804 654
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