CareDx Issues Statement on Supreme Court Decision Regarding Stanford-Licensed Patents

October 03, 2023 at 18:00 PM EDT

Decision has No Impact on CareDx’s Ability to Continue Providing AlloSure® nor Commitment to Transplant Innovation

CareDx Believes Decision Applies Equally to Other Diagnostics Patents, including Natera’s Transplant Diagnostic Patents

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 – acknowledges the Supreme Court’s decision not to review the Federal Circuit’s decision on the patent eligibility of three Stanford-licensed patents. CareDx notes the decision does not impact the Company’s ability to continue providing AlloSure® donor-derived cell-free DNA (dd-cfDNA).

While CareDx respectfully disagrees with the Supreme Court’s decision, the case law applies equally to other transplant diagnostics patents, including Natera’s, and CareDx has filed a motion to invalidate Natera’s patents on these same grounds.

CareDx remains committed to improving transplant patient outcomes by providing innovative and intelligent solutions throughout the entire patient journey. It is proud of the proprietary nature of its ground-breaking quantification method spurred by years of research and innovation in the field of transplant diagnostics that led to success where others failed.

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 impact created by Supreme Court’s decision (the “Decision”) not to review CareDx’s case on the eligibility of the three Stanford-licensed patents (the “Case”), the potential results that may be achieved by CareDx’s motion filing to invalidate Natera’s patents (the “Motion”), CareDx’s belief that the case law applies equally to other transplant diagnostics patents, including Natera’s (the “Belief”), and the estimated costs of the Case, including Motion.

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 related to the Case and Motion; risks that the Decision may have negative impact on CareDx’s products, competitive position in the market, royalty payments, and other patents, risks that CareDx’s motion may not be granted; risks that CareDx’s Belief may not be accurate; risks that the Case may take longer or cost more than CareDx expects; 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, 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.