TIDMRENX
RNS Number : 8895V
Renalytix PLC
12 April 2023
Renalytix plc
("Renalytix" or the "Company")
Data Supportive of KidneyIntelX Utility in Minorities and
Veterans to Be Presented at the National Kidney Foundation Spring
Clinical Meeting
In a clinical decision effectiveness study, KidneyIntelX
classified more Black vs non-Black patients as high risk for
progression of chronic kidney disease, resulting in increased
prescription of SGLT2-inhibitor
drug therapy
Additional study results illustrate how KidneyIntelX is aligned
with the Veteran's Health Administration care practice guidelines
for risk assessment in early-stage kidney disease and the
introduction of novel therapies and timely referral to clinical
specialists
LONDON and SALT LAKE CITY, April 12, 2023 (GLOBE NEWSWIRE) --
Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced that two
scientific presentations have been accepted at the upcoming
National Kidney Foundation Spring Clinicals Conference taking place
in Austin, Texas (April 11-15). The studies entitled the " Impact
of KidneyIntelX testing on novel medication prescription in a
diverse patient population" and "Diabetic kidney disease
epidemiology in US veterans" show the importance of using
KidneyIntelX bioprognosis in early stage kidney disease and
diabetes patients to blunt the effects of health inequity, help
guide proper drug prescription to patients in need, and support
established clinical guidelines to slow or stop unnecessary
progression to late stage kidney disease, kidney failure and
dialysis.
During National Kidney Month in March, Renalytix participated at
a national and global level by hosting several events including a
national webinar entitled, "Diabetic Kidney Disease: Importance of
Early Risk Assessment for Optimal Outcomes" with Dr. Joseph
Vassalotti, Clinical Professor of Medicine, in the Division of
Nephrology, at Icahn School of Medicine at Mount Sinai and Chief
Medical Officer for the National Kidney Foundation. The webinar is
now on-demand and available on www.kidneyintelx.com or via this
link.
National Kidney Foundation Clinical Spring Conference Data
Presentations Include:
Impact of KidneyIntelX testing on novel medication prescription
in a diverse patient population
KidneyIntelX was recently introduced into the Wake Forest-Atrium
Health System to predict progressive decline in kidney function. In
590 patients with (type 2 diabetes) T2D and early stage CKD,
despite similar eGFR, UACR and HbA1c in the Black vs. non-Black
populations, the proportion of Black patients in the high-risk
category was 3x higher than non-Black (15 vs. 5%). Identifying the
highest risk patients gives the potential to prescribe novel
medications, such as SGLT2-inhibitors to help stop or slow the
progression of disease. The KidneyIntelX risk score identified
those patients at highest risk which resulted in appropriately
selecting SGLT2-inhibitors for the right patients. Due to the
KidneyIntelX score, SGLT2-inhibitors usage markedly increased in
Blacks who were scored as high risk (8.3% pre-test to 25% usage
post-test) and increased from 19% to 32% in those scored as
intermediate risk. These data demonstrate that health care
providers can use KidneyIntelX for risk stratification to guide
treatment plans and can be implemented in population health
initiatives toward prevention of complications and improved
healthcare equity.
The data will be showcased from April 12-14 in the Poster Hall
at the Austin Convention Center and the e-poster is now online at
the NKF website.
Diabetic kidney disease epidemiology in US veterans
Diabetes is the leading cause of chronic kidney disease, which
is a major burden on the US Veterans Health Administration (VHA) at
a cost of approximately $18 billion in 2014 and an area of clinical
focus at the VHA. Identifying veterans at highest risk is essential
to define gaps in DKD management. In a patient cohort of more than
685,000 veterans with T2D and CKD, the authors identified a gap in
current standard of care in which patients with early stage DKD
(stages 1 and 2) may be left underdiagnosed or undetected, since
the majority of patients (79%) were first identified with CKD at
Stage 3a or 3b. More than one out of ten patients at earlier DKD
stages (G1A2 - G3b) progressed to the next or higher stage within a
year, and more than half of patients at earlier DKD stages
progressed to advanced stages or died within five years. These
findings demonstrate that T2D and CKD in veteran populations may
progress rapidly due to a higher prevalence of comorbidities in the
veteran population. In accordance with the goals of VHA Directive
1053, early recognition and management of CKD allows clinicians
more opportunities to protect kidney health and reduce the risk of
kidney failure.
This study demonstrates that the Renalytix KidneyIntelX solution
as a risk assessment tool for early-stage CKD is well aligned with
established Veteran's Health Administration care guidelines and the
2020 Directive 1053 recommending a validated risk prediction model
to support clinical decision making in the management of patients
with CKD.
The data will be showcased from April 12-14 in the Poster Hall
at the Austin Convention Center and the abstract is now online at
the NKF website.
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 / Lianne Applegarth Mob: 07980 541 893 / 07584 391 303
CapComm Partners
Peter DeNardo Tel: 415-389-6400 or investors@renalytix.com
About Kidney Disease
Kidney 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
people(2) , have chronic kidney disease (CKD). Nearly 95% of people
with CKD are in early stages 1-3(3) . 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.(3)
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(TM) 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 KidneyIntelX(TM)
KidneyIntelX(TM) is a laboratory developed test demonstrated to
be a reliable, bioprognostic(TM) 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 received
Breakthrough Device Designation from the U.S. Food and Drug
Administration and Renalytix has submitted for De Novo marketing
authorization. To learn more about KidneyIntelX and review the
evidence, visit www.kidneyintelx.com.
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 of
KidneyIntelX, the potential for KidneyIntelX to receive regulatory
approval from the FDA, the commercial prospects of KidneyIntelX, if
approved, including whether and to what extent KidneyIntelX will be
successfully adopted by physicians and distributed and marketed,
our expectations regarding the ability of KidneyIntelX to curtail
costs of chronic and end-stage kidney disease, optimize care
delivery, address systemic inequalities 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 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.
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