Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced that four
scientific presentations have been accepted at the upcoming
American Society of Nephrology (ASN) Kidney Week (November 3-6,
2022) taking place in Orlando, Florida.
The presentations include a cost-effectiveness
analysis that supports population-based KidneyIntelX testing for
prognosis of early stage Diabetic Kidney Disease (DKD) (stage
G1-G3b) as a cost effective strategy for a Medicare population in
comparison to standard clinical management tools to treat DKD, as
well as the first clinical utility findings from the multi-year
real world evidence study at a major healthcare system with an
emphasis on addressing disparities in healthcare access.
Scientific clinical and health economic
presentations include:
Prognostic Risk Score for Kidney Disease
Progression in African Americans Without Type 2 Diabetes by
Nadkarni GN, Takale D, Stapleton S, Fleming F, and Coca
SG:
Data will be presented on the KidneyIntelX
platform in a cohort of African Americans (AAs) with non-diabetic
CKD with and without the APOL1 risk genotype. The new model with
plasma sTNFR1, sTNFR2, and KIM-1 combined with clinical variables
accurately risk-stratified AAs with and without APOL1 risk genotype
for kidney outcomes. Thursday, November 3, 2022 from 10:00
AM to 12:00 PM at the Exhibit Hall, Orange County Convention
Center.
Examining the Role of KidneyIntelX in
Addressing Health Inequity in CKD by Freedman BI, Paige RA,
Spainhour MH, Bagwell BM, Houlihan JA, and Lord RW:
The KidneyIntelX risk score was assessed for its
ability to predict progressive decline in kidney function in
patients with T2D and early-stage CKD in a major healthcare system.
Initial results suggest that despite similar median eGFR and median
UACR levels, African American patients tested with KidneyIntelX
were three times more likely to be scored as high risk. It is hoped
that with continued use in the setting, KidneyIntelX may allow PCPs
and healthcare systems to optimize the allocation of treatments and
clinical resources to those at highest risk, beyond traditional
clinical metrics and potentially improve equity in outcomes.
Thursday November 3, 2022 from 10:00 AM to 12:00 PM at the
Exhibit Hall, Orange County Convention Center.
TNFR-1, TNFR-2, and KIM-1 Plasma
Concentrations after COVID-19 and Association with Kidney Function
by Chan L, Anandakrishnan N, Saha A, DeFronzo S, Mosoyan, Meliambro
K, G, Wisnivesky J, Nadkarni G, Stapleton S, Fleming F, Coca SG,
and Azeloglu E:
KidneyIntelX Biomarkers TNFR1, TNFR2, and KIM1
are associated with progression of kidney disease and these
biomarkers have not been evaluated in patients who have recovered
from COVID-19. In this study of patients who had COVID-19 and
recovered, at the baseline visit, KIM-1, TNFR-1, and TNFR-2 levels
were highest in patients who were previously hospitalized and had
acute kidney injury (AKI) during hospitalization. The degree of
biomarker elevation was associated with lower kidney function more
than one year post-COVID. Friday, November 4, 2022 from
10:00 AM to 12:00 PM at the Exhibit Hall, Orange County Convention
Center.
Cost-Effectiveness Analysis of a
Prognostic Risk Assessment Test for Diabetic Kidney Disease G1-G3b
in the United States by Cooper JT, Beltran K, Coca SG, and
Schneider, JE:
The KidneyIntelX risk score can assist primary
care providers in guiding resource utilization, prescription of new
therapeutic agents and improve efficiency of care among physicians.
The results concluded that population-based testing for prognosis
of progression with KidneyIntelX in a DKD G1-G3b population was a
cost-effective strategy for a Medicare population including factors
associated with quality of life improvements in comparison to
prognosis relying on the standard metrics of kidney function (eGFR)
or albuminuria (UACR) alone, while use of KidneyIntelX use in the
commercial population was shown to be a dominant strategy compared
to these standard kidney metrics alone. Saturday, November
5, 2022 from 10:00 AM to 12:00 PM at the Exhibit Hall, Orange
County Convention Center.
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.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
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™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 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.
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/kidneydisease/publications-resources/ckd-national-facts.html3 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, 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 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:Karla
GonyeRenalytix617-590-5731media@renalytix.com
Outside of the United
States:Walbrook PR LimitedPaul McManus / Lianne
Applegarth / Alice WoodingsTel: 020 7933 8780
or renalytix@walbrookpr.comMob: 07980 541 893 / 07584 391 303
/ 07407 804 654
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