This announcement contains
inside information for the purposes of Article 7 of the UK version
of Regulation (EU) No 596/2014 which is part of UK law by virtue of
the European Union (Withdrawal) Act 2018, as amended ("MAR"). Upon
the publication of this announcement via a Regulatory Information
Service, this inside information is now considered to be in the
public domain.
Renalytix
plc
("Renalytix" or the "Company")
Medicare
Issues Final Coverage Determination for kidneyintelX.dkd
Company
has Achieved Prerequisites for Growing Test Adoption with FDA
Authorization, Clinical Outcomes Data, Inclusion in Clinical
Guidelines, and Broad Insurance Coverage
LONDON and NEW YORK, 14 June
2024 - Renalytix
plc (NASDAQ: RNLX) (LSE:
RENX) announces that on June 13,
2024 Medicare issued a final Local Coverage
Determination ("LCD") for the Company's kidneyintelX.dkd testing.
The final LCD can be accessed at LCD
- KidneyIntelX and KidneyIntelX.dkd Testing (L39726)
(cms.gov), and is effective for
dates of service on or after August 1, 2024. The established
Medicare price for kidneyintelX.dkd is $950 per test.
Distinct CPT Codes (Common Procedural Terminology Codes) have been
established for kidneyintelX.dkd and is published in CMS' 2024
Clinical Lab Fee Schedule.
The LCD specifies coverage for use
of kidneyintelX.dkd for patients with diagnosed Type 2 diabetes and
Stage 1-3b Chronic Kidney Disease is reasonable and necessary. Any
specified limitations for use conform to the U.S. Food and
Drug Administration ("FDA") label for kidneyintelX.dkd. The
LCD was issued by National Government Services ("NGS").
NGS is a subsidiary of Elevance Health, Inc. (previously Anthem,
Inc.), a Medicare Administrative Contractor responsible for claims
processing for testing performed in the Company's New York
City laboratory.
"With final Medicare Coverage, an
FDA authorization, and an April recommendation in the international
clinical guidelines, kidneyintelX.dkd is poised to be a
preventative medicine standard for 14 million people in the United
States living with diabetes and kidney disease. We expect this
Medicare coverage will prompt additional major coverage decisions
and help accelerate testing adoption," said James McCullough
CEO of Renalytix. "We remain focused on incremental sales
growth in targeted US regions with a now significantly lower cost
of operations."
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
Paul McManus / Alice Woodings
/
Charlotte Edgar
|
Tel: 020 7933
8780 or renalytix@walbrookpr.com
Mob: 07980
541 893 / 07407 804 654 /
07884 664
686
|
|
|
CapComm Partners
|
|
Peter DeNardo
|
Tel:
415-389-6400 or
investors@renalytix.com
|
About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX)
is an artificial intelligence enabled in-vitro diagnostics and laboratory
services company that is the global founder and leader in the field
of bioprognosis™ for kidney health. In late 2023, our
kidneyintelX.dkd test was recognized as the first and only
FDA-authorized prognostic test to enable early-stage CKD (stages
1-3b) risk assessment for progressive decline in kidney function in
T2D patients. By understanding how disease will progress, patients
and clinicians can take action earlier to improve outcomes and
reduce overall health system costs. For more information,
visit
www.renalytix.com.
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:
timing and outcome of LCD determination, and the commercial prospects of KidneyIntelX. Words such as "anticipates," "believes," "estimates,"
"expects," "intends," "plans," "seeks," and similar expressions are
intended to identify forward-looking statements. The Company may
not actually achieve the plans and objectives disclosed in the
forward-looking statements, and you should not place undue reliance
on the Company's 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; and that the Company has only recently
commercially launched KidneyIntelX. These and other risks are
described more fully in the Company's filings with
the Securities and Exchange Commission (SEC), including
the "Risk Factors" section of its annual report on Form 10-K filed
with the SEC on September 28, 2023, and any
risks that may be contained in any subsequent filings that the
Company makes with the SEC . All information in this
press release is as of the date of the release, and the Company
undertakes 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.