Renalytix plc (LSE: RENX) (NASDAQ:RNLX) announces that the
U.S. Food and Drug Administration (FDA) has granted De Novo
marketing authorization for its KidneyIntelX.dkd ™ prognostic test.
This affirms KidneyIntelX as a first-in-class, artificial
intelligence enabled prognostic testing platform to guide care
management for adults with type 2 diabetes and early-stage chronic
(diabetic) kidney disease. Renalytix believes FDA authorization
will lead to increasing test adoption, informing clinical
guidelines, expanding insurance coverage, and pursuing additional
international regulatory approvals.
“Meeting the rigorous safety, clinical and analytical
validation, and scientific data requirements of an FDA review, from
Breakthrough Device designation to De Novo marketing authorization,
is a landmark event for health care providers and patients with
diabetic kidney disease,” said James McCullough, CEO of Renalytix.
“With this approval a new class, Prognostic Test
for Assessment of Chronic Kidney Disease Progression, has
been established by the FDA, providing a roadmap for future
expansion of KidneyIntelX into new indications and products.”
KidneyIntelX.dkd accurately stratifies patients into three risk
levels (low, moderate, and high). This result provides
comprehensive information on patient risk for progressive decline
in kidney function within five years, independently of the current
standard of care measures. KidneyIntelX.dkd is the name used to
differentiate tests to be provided under the De Novo marketing
authorization by the FDA from those provided under the KidneyIntelX
name as a Laboratory Developed Test.
Since being introduced as a Laboratory Developed Test (LDT),
KidneyIntelX results have been reported on approximately 10,000
patients in the United States and there has been broad insurance
payment including from Medicare and many private payers.
The KidneyIntelX platform combines blood-based biomarkers with
clinical variables using an artificial intelligence enabled
algorithm, providing reliable and actionable information to guide
care in large, at-risk patient populations. KidneyIntelX is based
on technology developed at the Icahn School of Medicine at Mount
Sinai in New York, NY, and licensed to Renalytix.
About Chronic (Diabetic) 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.
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.html3
https://www.cdc.gov/diabetes/data/statistics-report/index.html4
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/
About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) 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
technology platform to introduce novel laboratory developed and FDA
approved tests to enable risk assessment and appropriate care
management in adult patients with type 2 diabetes and early-stage
CKD. By gaining early visibility into risk for progressive decline
in kidney function, and an understanding of associated actionable
insights, patients and health care providers may benefit from
improved outcomes and decreased costs. For more information, visit
our Company website at www.renalytix.com and our product website at
www.kidneyintelx.com.
KidneyIntelX is based on technology developed at the Icahn
School of Medicine at Mount Sinai in New York, NY, and licensed to
Renalytix. Mount Sinai and Mount Sinai faculty have a financial
interest in Renalytix. Mount Sinai also has representation on the
Renalytix Board of Directors.
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 commercial prospects of
KidneyIntelX and KidneyIntelX.dkd, including whether KidneyIntelX
and KidneyIntelX.dkd will be successfully adopted by physicians,
inform clinical guidelines, 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 reimbursement decisions 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 the “Risk
Factors” section of our annual report on Form 20-F filed with the
SEC on October 31, 2022, 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:
Renalytix:
media@renaltyix.comKarla Gonye:
kgonye@renaltyix.com or
617-590-5731
Russo Partners, LLCDavid
Schull: david.schull@russopartnersllc.com
or 858-717-2310Ignacio Guerrero-Ros,
PhD:
ignacio.guerrero-ros@russopartnersllc.com
or 646-942-5604
Outside of the United States:Walbrook PR
LimitedPaul McManus/Lianne Applegarth/Alice
Woodings
Tel: 020 7933 8780 or
renalytix@walbrookpr.com Mob: 07980 541
893 / 07584 391 303 / 07407 804 654
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