Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) today announced that
the United States Government has granted the company a 10-year
Governmentwide Acquisition Contract (GWAC) to provide KidneyIntelX
early-stage kidney disease bioprognostic™ testing services. The
contract, offered through the General Services Administration
(GSA), covers laboratory testing services that can be provided
through more than 140 U.S. government departments, agencies and
affiliates, including the U.S. Veterans Administration (VA),
Department of Defense (DoD) military branches (Army, Navy, Air
Force, and Marines), and Indian Health Services (IHS). The contract
is effective as of April 15, 2021 and has a five-year term with a
five-year extension option, and is structured as an Indefinite
Delivery, Indefinite Quantity (IDIQ) contract providing for an
unlimited quantity of services over the contract term. Under the
contract, KidneyIntelX pricing is set at $950 per reportable
result.
With the GSA contract in effect, KidneyIntelX testing is now
available through the Federal Supply Schedule. Individual
physicians operating within government sponsored healthcare
programs can now order KidneyIntelX testing for their patients with
diabetic kidney disease. Details about the GSA award and how to
order the test can be found here.
The GSA contract simplifies structuring service agreements with
VA facilities, military installations, and tribal nations. The
contract also facilitates contracting with the VA’s regional
healthcare networks (Veterans Integrated Service Networks or VISNs)
to cover KidneyIntelX testing for their eligible patients.
The process to be granted a GSA contract can be considered
further support for the quality and importance of KidneyIntelX
testing. Securing a contract requires an application and rigorous
review against specific criteria, including the status of the
provider, the quality and dependability of the service provided,
and the need for the testing service.
Dr. James Post, Nephrologist and Chief of Internal Medicine at
the James J. Peters VA Medical Center in the Bronx, N.Y.,
commented, “Access to KidneyIntelX testing represents a significant
development in the early detection, intervention and management of
patients at risk for chronic kidney disease. With the clinical
information provided by the KidneyIntelX risk score report, primary
care physicians can identify and intervene early in the management
of patients who are on a path for renal failure prior to direct
involvement of a nephrologist or the need for dialysis.”
“This provides the opportunity for RenalytixAI to support our
veterans, active military and Native American communities, and to
expand our health system care delivery model,” commented Tom
McLain, President at RenalytixAI. “Achieving this contracting
milestone allows us to make KidneyIntelX available to patients
throughout the U.S. government healthcare system. Executing on our
market access strategy represents a substantial commercial
opportunity for RenalytixAI.”
The GSA contract enables RenalytixAI to initiate efforts towards
multiple integrated model deployments with government hospital
systems. To support these efforts, RenalytixAI has formed a market
access team focused on contracting with VA, DoD, and IHS facilities
as well as securing coverage agreements with VISNs and the DoD’s
TRICARE program to provide broad access to KidneyIntelX testing.
TRICARE is the healthcare program for uniformed service members,
retirees, and their families. In addition, RenalytixAI plans to
expand access to veterans who could benefit from KidneyIntelX
testing as part of its health system partnership programs. Several
academic medical centers also provide clinical support to VA
facilities.
About Kidney DiseaseKidney 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, or 37 million people,
currently have chronic kidney disease (CKD). 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 KidneyIntelXKidneyIntelX, is a
first-of-kind, bioprognosticTM platform that employs a proprietary
artificial intelligence-enabled algorithm to combine diverse data
inputs, including validated blood-based biomarkers, inherited
genetics, and personalized patient data from electronic health
record, or EHR, systems, to generate a unique patient risk score.
This patient risk score enables prediction of progressive kidney
function decline in chronic kidney disease, or CKD, allowing
physicians and healthcare systems to optimize the allocation of
treatments and clinical resources to patients at highest risk.
About the General Services Administration Contracting
ProgramThe General Services Administration (GSA) is an
independent agency of the United States government established in
1949 to help manage and support the basic functioning of federal
agencies. Their responsibilities include the Federal Acquisition
Service. The GSA Schedule (also referred to as Multiple Award
Schedule (MAS) and Federal Supply Schedule) is a long-term
governmentwide contract with commercial firms providing federal,
state, and local government buyers access to more than 11 million
commercial products and services. GSA contracts fix the rate paid
for government work making it much easier to structure individual
agency and department contracts. Listing on the Federal Supply
Schedule also allows purchases up to defined minimum thresholds
without a contract. Laboratory and medical services covered under
GSA contracts are generally provided to military veterans, active
military, and Native American Tribes. Laboratory services access
can also be provided to certain employees of the Federal government
including members of the US Senate and US House of
Representatives.
About RenalytixAIRenalytixAI (LSE: RENX)
(NASDAQ: RNLX) is a developer of artificial intelligence-enabled
clinical in vitro diagnostic solutions for kidney disease, one of
the most common and costly chronic medical conditions globally. The
Company’s lead product is KidneyIntelX, which has been granted
Breakthrough Designation by the U.S. Food and Drug Administration
and which is being designed to help make significant improvements
in kidney disease prognosis, transplant management, clinical care,
patient stratification for drug clinical trials, and drug target
discovery (visit www.kidneyintelx.com). For more information, visit
www.renalytixai.com.
Sources1
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.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 for KidneyIntelX to receive regulatory
approval from the FDA, the commercial prospects of KidneyIntelX, if
approved, including whether KidneyIntelX will be successfully
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 28, 2020,
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:Jennifer
MoritzZer0 to 5ive for RenalytixAI(917)
748-4006jmoritz@0to5.com
Outside of the United States:Walbrook PR
Limited Paul McManus
/ Lianne CawthorneTel: 020 7933 8780 or
renalytix@walbrookpr.comMob: 07980 541 893 / 07584 391 303
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