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CareDx Announces Proposed Draft LCD That Affirms Surveillance Testing Coverage for Solid Organ Transplant Rejection

By: via Business Wire

Draft Policy Recognizes the Importance of Surveillance Testing for Early Detection of Allograft Rejection in Kidney, Heart, and Lung

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – announced the release of a proposed draft Local Coverage Determination (LCD) related to molecular testing for solid organ allograft rejection. There is no change in current coverage and the draft LCD is open for comment through August 31, 2025.

The draft policy would continue to provide coverage for surveillance testing for kidney, heart, and lung transplant patients without a tie to protocol biopsy, underscoring the value of this important non-invasive molecular testing for solid organ transplant patients.

In addition, the draft policy introduces a bundled payment concept for surveillance testing. The Company is reviewing the draft coverage and payment policy and anticipates providing additional information during its upcoming earnings call on August 6, 2025.

“We believe publication of this draft policy solidifies coverage for surveillance testing and supports our longstanding position that our tests improve health outcomes for transplant patients,” said John W. Hanna, President and CEO of CareDx. “We do not expect changes in the use of our testing in response to this draft LCD and remain deeply committed to patient care and providing access to our testing. We look forward to providing feedback on the draft LCD through the public comment process.”

The proposed LCD is available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40059&ver=8&contractorName=all&contractorNumber=all&updatePeriod=1156&sortBy=updated&bc=13

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 Statement

This press release includes forward-looking statements, including statements regarding the potential benefits and results that may be achieved with AlloSure®, AlloMap® and HeartCare®, the use of our tests, and reimbursement coverage. 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 numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx’s control, that could cause the actual results to differ materially from those projected, including general economic and market factors, and global economic and marketplace uncertainties, among others discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed by CareDx with the SEC on April 30, 2025, 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. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

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