CareDx Continues Strategic Expansion into Hematology Oncology with Pharmacokinetic and Monitoring Assays for Cell Therapy Patients

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 – today announced that CareDx will partner with TC BioPharm to perform pharmacokinetic analysis using its AlloCell™ solution in the ACHIEVE clinical trial.

AlloCell has been used in ten prior cell therapy clinical trials and with the addition of the ACHIEVE trial is being actively used in four clinical trials.

The ACHIEVE clinical trial is an adaptive, open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008, an allogeneic gamma-delta T-cell therapy for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).

“This partnership builds upon our growth strategy to expand into hematology oncology with pharmacokinetic and monitoring assays for patients undergoing cell therapy,” said Marica Grskovic, PhD, CareDx Chief Strategy Officer. “We are thrilled to continue to progress the science of allogeneic cell therapy for patients battling acute myeloid leukemia.”

“Our partnership with CareDx is a significant milestone,” said Alison Bracchi, Executive Vice President of Clinical Operations at TC BioPharm. “The collaboration is pivotal to the development and optimization of TCB008 as a therapy for acute myeloid leukemia and other blood cancers.”

CareDx's AlloCell test, a sensitive solution for pharmacokinetic monitoring of allogeneic immune and stem cell therapies will be used to evaluate the expansion and persistence of TCB008 in patients enrolled in the ACHIEVE trial. It is expected that the expansion and persistence data will provide an understanding of the duration and effect of TCB008 gamma-delta T-Cells in reconstituting the immune system of acute myeloid leukemia patients enrolled in the ACHIEVE trial.

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. and its strategic partnership with TC BioPharm, including statements regarding the partnership’s ability to drive innovation, the ACHIEVE clinical trial, and the potential benefits and results that may be achieved with AlloCell. 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 actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of the strategic partnership of the ACHIEVE clinical trial, or of AlloCell itself. These statements are also subject to general economic and market factors; and other risks 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, 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 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the Quarterly Report on Form10-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. 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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