Medicare Issues Final Coverage Determination for kidneyintelX.dkd
14 Juin 2024 - 1:00PM
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 |
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Stifel (Nominated Adviser, Joint Broker) |
Tel: 020 7710 7600 |
Alex Price / Nicholas Moore / Nick Harland / Samira Essebiyea |
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Investec Bank plc (Joint Broker) |
Tel: 020 7597 4000 |
Gary Clarence / Shalin Bhamra |
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Walbrook PR LimitedPaul McManus / Alice Woodings
/Charlotte Edgar |
Tel: 020 7933 8780 or renalytix@walbrookpr.comMob:
07980 541 893 / 07407 804 654 / 07884 664 686 |
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CapComm Partners |
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Peter DeNardo |
Tel: 415-389-6400 or investors@renalytix.com |
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About RenalytixRenalytix (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 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: 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.
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