CareDx Announces District Court Reverses Jury Decision in Patent Infringement Case Overturning Prior $96 Million Verdict

Business Wire 25-Feb-2025 7:05 AM

All Patent Claims Asserted Against CareDx are Found to Be Invalid

CareDx, Inc. (NASDAQ:CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that the District Court overturned the jury verdict in patent litigation brought by a competitor.

The District Court ruled that the patents asserted against CareDx are invalid. The Court reached this determination because the patents failed to describe the claimed invention in sufficient detail. CareDx believes that the Court's decision brings this lawsuit to its rightful legal outcome and is a win for transplant patients.

CareDx developed the industry's first donor-derived cell-free DNA assay, AlloSure®, for identifying organ rejection in transplant patients. AlloSure was first commercially introduced in 2017 for kidney transplant patients and subsequently was validated for heart and lung transplant patients.

If the plaintiff, Natera, appeals, CareDx will continue to vigorously defend its technology.

In addition, the patent that is the basis of the $96 million verdict is also subject to a pending ex parte reexamination before the United States Patent and Trademark Office ("PTO"). On February 14, 2025, a PTO examiner issued a non-final Office action rejecting the claims CareDx was found to have infringed in the litigation.

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 overturning of the jury verdict in the patent infringement case brought by Natera, the non-final Office action issued by the PTO, and the impact of these decisions on CareDx and the ability of CareDx to defend itself in the future. 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 the impact of the verdict differs from CareDx's estimates; general economic and market factors; 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, 2023 filed by CareDx with the SEC on February 28, 2024, the quarterly report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024, the quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed by CareDx with the SEC on November 4, 2024, 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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CareDx, Inc. Media Relations Anna Czene 818-731-2203 aczene@caredx.com

Investor Relations Caroline Corner investor@caredx.com