CareDx Comments on Issuance of Proposed LCD for Molecular Testing for Solid Allograft Rejection
11 Agosto 2023 - 8:00AM
Business Wire
CareDx Welcomes Open Process to Gain Transplant
Community Feedback on Critical Medicare Coverage Decision
CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine
company focused on the discovery, development, and
commercialization of clinically differentiated, high-value
healthcare solutions for transplant patients and caregivers – today
commented on the issuance of proposed changes to the Local Coverage
Determination (LCD) MolDX Molecular Testing for Solid Organ
Allograft Rejection that covers AlloSure®, AlloMap® and
HeartCare.
CareDx is pleased that MolDX is providing the public with the
opportunity to participate in an open and transparent process, as
advocated by CareDx and many others across the transplant
community. In the proposed LCD (DL38568) MolDX continues to
recognize the value of surveillance testing in certain scenarios,
as well as other uses for these tests in transplant; however, the
proposed LCD would change the existing LCD to inappropriately
restrict coverage in a manner similar to the restrictions that
CareDx believes were impermissibly introduced in the Medicare
Billing Article revisions issued on March 2 and May 4, 2023.
MolDX and Noridian have opened a public comment period that
extends through September 23, 2023, to solicit feedback from
clinicians, patients, and the transplant community for
consideration in drafting a final LCD. CareDx will continue to
review the proposed LCD and looks forward to providing comments on
the draft policy. CareDx believes that broad coverage of these
tests based upon the clinicians’ assessment of need for their
transplant patients is both appropriate and also consistent with
MolDX’s longstanding coverage policies.
“While CareDx welcomes an open process for gaining public
feedback on the proposed LCD as required by CMS rules, we are
disappointed in the way the coverage policy was changed with two
Billing Articles issued in the six months prior to this proposed
LCD. This has created unnecessary clinician confusion, chaos, and
disruption to patient care,” said Reg Seeto, CEO and President of
CareDx. “CareDx will continue to fight for access to transplant
innovation for these highly vulnerable patients.”
CareDx is the only company covered under this LCD that is 100
percent focused on serving transplant patients. CareDx has invested
hundreds of millions of dollars and over two decades to support the
transplant community, leading with innovation. CareDx is the first
and only company approved by MolDX for gene expression profiling in
heart with AlloMap Heart, the first and only approved for
donor-derived cell-free DNA (dd-cfDNA) in lung with AlloSure Lung
and the first dd-cfDNA approved in kidney with AlloSure Kidney.
CareDx is also the first and only approved in multimodality with
HeartCare.
About CareDx – The Transplant Company™
CareDx, Inc., headquartered in Brisbane, California, is a
leading precision medicine solutions company focused on the
discovery, development, and commercialization of clinically
differentiated, high-value healthcare solutions for transplant
patients and caregivers. CareDx offers testing services, products,
and digital healthcare solutions along the pre- and post-transplant
patient journey and is the leading provider of genomics-based
information for transplant patients. For more information, please
visit: www.CareDx.com.
Forward Looking Statements
This press release includes forward-looking statements related
to CareDx, Inc., including statements regarding the potential
benefits and results that may be achieved with CareDx’s HeartCare,
AlloSure and AlloMap, and the proposed LCD for Molecular Testing
for Solid Allograft Rejection (the “LCD”). These forward-looking
statements are based upon information that is currently available
to CareDx and its current expectations, speak only as of the date
hereof, and are subject to risks and uncertainties that could cause
actual results to differ materially from those projected, including
risks that CareDx does not realize the expected benefits of
HeartCare, AlloSure or AlloMap; the potential impact of a final LCD
on patient care; general economic and market factors; regulatory
risks; and other risks discussed in CareDx’s filings with the SEC,
including the Annual Report on Form 10-K for the fiscal year ended
December 31, 2022 filed by CareDx with the SEC on February 27,
2023, the quarterly report on Form 10-Q for the quarter ended March
31, 2023 filed by CareDx with the SEC on May 10, 2023, the
quarterly report on Form 10-Q for the quarter ended June 30, 2023
filed by CareDx with the SEC on August 8, 2023, and other reports
that CareDx has filed with the SEC. Any of these may cause CareDx’s
actual results, performance, or achievements to differ materially
and adversely from those anticipated or implied by CareDx’s
forward-looking statements. CareDx expressly disclaims any
obligation, except as required by law, or undertaking to update or
revise any such forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20230811202647/en/
CareDx, Inc.
Media Relations Anna Czene 818-731-2203 aczene@caredx.com
Investor Relations Greg Chodaczek Investor@caredx.com
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