Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced the
publication of a clinical utility study in The American Journal of
Managed Care confirming Primary Care Physicians (PCPs) understand
the value of KidneyIntelX™ in determining appropriate
guideline-recommended treatment decisions in their adult patients
with type 2 diabetes (T2D) and early chronic kidney disease stages
1-3 (diabetic kidney disease). The study of 401 geographically
diverse clinicians was conducted by Boston Healthcare Associates, a
third party specialized in medical device evaluation, clinical
development, and data management.
The published study complements recently published data
from a real-world evidence clinical utility study of 1,112 adult
DKD patients presented at the recent American Diabetes Association
82nd Scientific Sessions and the European Congress of Internal
Medicine. These combined published results confirm the significant
benefit of using KidneyIntelX in the Primary Care setting to direct
care towards improving kidney health and reducing the significant
financial burden associated with DKD.
“The study publication announced today is a key element of a
comprehensive evidence development program,” said Tom McLain,
President of Renalytix. “This program was designed to address the
evidence requirements of payers, regulators, clinicians, and
guideline setting bodies. The increasing volume of real-world
evidence being generated from our health systems partnerships,
presented at the ADA conference, confirms clinical utility, and
indicates adoption of KidneyIntelX in the clinical setting.”
“We now have evidence that indicates that KidneyIntelX is not
only clinically valued by PCPs but is also useful in aiding
clinical decision making in the real-world setting, helping ensure
that patients are on the right care path at the right time," said
Michael J. Donovan, Ph.D., M.D., Chief Medical Officer of
Renalytix. “The adoption rate among PCPs as reported at the 2022
ADA late-breaking poster session on our real-world evidence study
and the published clinical utility study underscores both the
clinical need and clinician confidence in using KidneyIntelX to
provide actionable risk stratification. In the real-world setting,
this was associated with a 6-fold increase in the initiation of
guideline-recommended treatments, and a nearly 3-fold increase in
appropriate referrals.”
Results demonstrate growing awareness among PCPs in
terms of the recognized value of KidneyIntelX in clinical decision
making:
- The significance of these results was supported by a rigorous,
analytical framework created to be highly representative of
real-world care today and included 42 unique patient profiles and
was designed to show what happens when KidneyIntelX is included vs.
not included in patient care.
- The KidneyIntelX test had a greater relative importance than
the standard of care (eGFR and UACR) for PCPs in prescribing
guideline-recommended therapies and deciding when to consult with a
specialist.
- 98% of PCPs responded they were somewhat, very, or extremely
likely to use KidneyIntelX to predict which of their patients will
experience rapid progressive kidney function decline.
- A behavioral shift among PCPs was examined after the
introduction of KidneyIntelX. Approximately 80 percent of PCPs in
the study noted risk assessment would support the decision to take
more aggressive, guideline recommended clinical actions in
high-risk, early stage (stage 1 through 3b) diabetic kidney disease
patients.
“Adoption of KidneyIntelX among primary care physicians could
play an important role in changing how we treat patients with
diabetic kidney disease, by allowing for timely intervention in the
early stages 1-3 of disease, when primary care physicians have the
power to delay or prevent progression,” said Dr. Stephen Brunton,
MD, FAAFP, CDCES, Primary Care Education Consortium, Family
Practitioner and Executive Director of the Primary Care Metabolic
Group. “This study adds to the growing body of clinical utility
evidence showing how advanced prognosis tools like KidneyIntelX
could help make more informed decisions in the management of
patients, especially in early disease, and limit progression to end
stage kidney disease.”
A total of 401 PCPs participated in the published clinical
utility study. Respondents were recruited to ensure broad
generalizability of results based on geographic and care model
distribution, as well as a representative distribution of types of
health insurance coverage. The geographic distribution of
respondents was representative of the geographic distribution in
the United States. The study was funded by a research grant from
Renalytix.
The full study is available here.
About Kidney DiseaseKidney disease is a public
health epidemic affecting over 850 million people
globally.2 The Centers for Disease Control and Prevention
estimates that 15% of U.S. adults, or over 37 million people3, have
chronic kidney disease (CKD). Nearly 95% of people with CKD are in
early stages 1-34. 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 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 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 KidneyIntelX™KidneyIntelX™ is a
laboratory-developed test demonstrated to be a reliable,
bioprognostic™ 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.
Sources1 Saran R, Robinson B, Abbott KC,
Bragg-Gresham J, Xiaoying C. U.S. Renal Data System 7 2019 Annual
Data Report: Epidemiology of Kidney Disease in the United States.
Am J 8 Kidney Dis. 2020;75(1):S1-S64. 2
https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/3 https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html4 https://www.cdc.gov/kidneydisease/basics.html
Forward Looking StatementsStatements 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 and to what extent 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:Andria
ParksRenalytix(801)-447-2698media@renalytix.com
Outside of the United States:Walbrook
PR LimitedPaul McManus / Lianne Applegarth / Alice
Woodings
Tel: 020 7933 8780 or renalytix@walbrookpr.comMob: 07980
541 893 / 07584 391 303 / 07407 804 654
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