New Data Highlights Latest Advancements to AlloSeq Tx Used in Solid Organ and Stem Cell Transplant HLA Typing

CareDx Introduces Newest Enhancements to QTYPE for Rapid Deceased Donor HLA Typing

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 new data and product enhancements being presented at the 50^th annual meeting of the American Society for Histocompatibility and Immunogenetics (ASHI). The meeting takes place in Anaheim, California, from October 21-25, 2024.

The latest advances across CareDx’s portfolio of AlloSeq™ NGS-based HLA typing solutions are being featured demonstrating its clinical utility in living organ donation typing and bone marrow transplantation. CareDx is also launching its newly improved QTYPE^® solution which now includes single bead antigen resolution to facilitate virtual crossmatching in deceased donor typing for faster transplant decisions.

“We are committed to delivering the most advanced HLA typing solutions to optimally support pre-transplant recipient and donor matching in both solid organ and stem cell transplantation,” said John W. Hanna, CareDx President and CEO. “We’re excited to share our latest product innovations and supporting data at this year’s ASHI meeting.”

CareDx is hosting a symposium at the meeting to share its latest product advancements. Annette M. Jackson, PhD, F(ACHI), from Duke University, a leading expert in the field of clinical transplant immunology, will speak at the symposium about her lab’s latest findings identifying risk haplotypes in pediatric nephrotic syndrome. CareDx speakers, Curt Lind, PhD, VP and Head of Lab Products R&D, and Beata Kmiec, PhD, Senior Product Manager, will share CareDx’s latest product innovations including a novel approach to HLA haplotyping and the latest advancement to QTYPE, a real-time PCR solution that now combines high coverage redundancy and single antigen resolution on a single run.

“Our clinical research team at Duke is grateful to partner with CareDx to validate the discovery of new HLA associated diseases such as pediatric steroid sensitive nephrotic syndrome, a rare but serious condition that can lead to kidney failure,” said Annette M. Jackson, PhD, F(ACHI), Associate Professor, Departments of Surgery & Immunology Chief, Clinical Transplantation Immunology Research Director, Clinical Transplantation Immunology Laboratory Duke University.

Key data to be presented at ASHI 2024:

• Validation of AlloSeq Tx 11, NGS Typing of 11 Classical HLA Loci. Morris T, Willis A, Kmiec B, et al. This study shows that the addition of new probes in AlloSeqTx 11 increases the sequencing coverage of Class II loci, for 99.9% concordant results leading to fewer typing ambiguities.
• Assessment of Buccal Swab Performance Utilizing Hybrid Capture HLA Typing. Morris T, Willis A, Kmiec B, et al. This study showed that using AlloSeq Tx 17 hybrid capture method had a 100% success rate with fragmented buccal DNA, compared to 43% with alternate methods using long range PCR.
• Haplotyping in 3-D – Long-distance phasing of short NGS reads – a novel approach to HLA haplotyping. Lind C, Morris T, Willis A, et al. This study showed that using LinkPrep™ reagents from Dovetail Genomics paired with AlloSeq Tx hybrid capture technology and AlloSeq Assign successfully enable both high resolution genotyping and haplotyping without the need for family studies.

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 AlloSeq, QTYPE, and other CareDx products and statements regarding the data to be presented at the annual American Society for Histocompatibility and Immunogenetics meeting. 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 AlloSeq, QTYPE, and other CareDx products; risks that the data to be presented at the ASHI may not follow the agenda as stated in this press release; risks that the findings in the studies supporting the data may be inaccurate; 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 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, 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. 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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