REG - Renalytix PLC - Medicare issues final Local Coverage Determination

RenalytixAnnouncement

14/06/2024 09:15

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RNS Number : 4910S  Renalytix PLC  14 June 2024

 

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
(https://urldefense.com/v3/__https:/renalytix.com/__;!!OPvj_Mo!5NjuO3d4ZKKNy3CAS5zrlIoL4v77Z1jUxLn_SzH6VpmCLKJ4uV-vaEXz1QL81Z_81bVMj7e5kEYRXU0_CqbZ$)
 (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)
(https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39726&ver=3&contractorName=1&contractorNumber=all&proposedStatus=all&sortBy=title&bc=10)
, 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 (http://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                                            Tel: 020 7933 8780 or renalytix@walbrookpr.com

                                                              (mailto:renalytix@walbrookpr.com)
 Paul McManus / Alice Woodings /

                                                              Mob: 07980 541 893 / 07407 804 654 /
 Charlotte Edgar

                                                                07884 664 686

 CapComm Partners
 Peter DeNardo                                                  Tel: 415-389-6400 or investors@renalytix.com (http://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
(https://www.globenewswire.com/Tracker?data=cwptls73WOXXvXZElSs3a2reoferxCWvBpaKyejhK9PSyJybCe1RUrHHx3-AhQrHBtzbuyNE2_1PQpSvEYREQK8LxkfY8s7gpb_VuRJmGhAI9JKKWZjvt-05FOQJ9ERDnn2CUUsRBUUidnavSIKVEnBKEYHCV7D6JUNxeV5-pdXJh_jdHbXPDhXgx0eUmgXXzpbXGMkTlKTYy5JA1S_OaAF8hqjwoJBdo_1P3A1vfd4EsWBV9RicuAt4kurR_7Vd)
.

 

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.

 

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