CareDx Announces New IVD Products and IVDR Certification for AlloSeq® Tx and QTYPE® at the 2025 American Society of Histocompatibility & Immunogenetics Annual Meeting

October 06, 2025 at 07:05 AM EDT

Furthers Global Leadership in Donor Organ and Transplant Recipient 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 innovations and products that will be featured at The American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, held October 6th to 10th in Orlando, Florida. The company also announced that its AlloSeq^® Tx and QTYPE^® products have received certification for compliance to the In Vitro Diagnostic Regulation (IVDR) in the European Union.

“This week at ASHI 2025, we will highlight our continued investment in creating life changing solutions that allow transplant patients to thrive,” said John Hanna, President and Chief Executive Officer. “The new product innovations and regulatory milestone underscore CareDx’s commitment to delivering high-quality HLA typing diagnostics and strengthens our position as the global leader of transplant solutions.”

Product Launches and Technology Previews at ASHI 2025

AlloSeq Tx11: Launching at ASHI 2025, this next-generation HLA typing solution features enhanced Class II coverage to improve donor-recipient matching in both solid organ and stem cell transplantation. It also incorporates key non-HLA markers—ABO, CCR5, LIMS1, and APOL1—to support broader transplant risk profiling. AlloSeq Tx works well with low-quality samples, prevents allele dropouts, reduces retesting, and allows flexible sample pooling.

SCORE 7 Software: A modernized analysis application for QTYPE, designed for scalability and regulatory alignment, supporting future ABO typing and IVDR compliance. QTYPE is CareDx’s rapid HLA typing solution, designed for low-to-intermediate resolution HLA typing using real-time PCR (RT-PCR) technology, optimized for speed and precision in transplant workflows.

Novel HLA Typing Assay: Available in an Early Access Program, this potentially disruptive technology offers same-day, long-read-based genotyping with rapid turnaround and flexible throughput, featuring a novel probe design for improved robustness and reduced allele dropout risk.

ABO Genotyping: CareDx will present a poster, “Rapid ABO Genotyping Assay in Combination with HLA Genotyping”, demonstrating the validation of a new molecular assay designed to improve ABO blood group determination in transplant settings. Conducted across three clinical sites, the study demonstrated 100% concordance between the rapid QTYPE ABO assay and established molecular methods in both genotype and phenotype results.

The poster underscores the clinical importance of accurate ABO typing—particularly in distinguishing subgroups such as A2—which can expand donor eligibility and support more flexible organ allocation strategies. By integrating ABO and HLA genotyping into a single qPCR-based workflow, the assay offers faster turnaround, reduced cost, and streamlined resource use, which could make it especially valuable for transplant centers managing ABO-incompatible transplants.

Sponsored Session

CareDx will lead a dedicated User Group Meeting titled “ABO Histocompatibility in Transplantation: Current Status, Unmet Needs, and Future Directions”. The session will feature leading experts from Brigham and Women’s Hospital, LifeLink Foundation, and the University of Alberta, addressing:

The clinical relevance of ABO antibodies in transplant rejection;
Genotype vs. phenotype discrepancies and the need for improved resolution;
The role of fucosyltransferase genes and Exon 1 analysis in advancing ABO typing; and
International efforts to standardize ABO compatibility testing.

Reinforcing its leadership in a growing global market, CareDx will showcase these products and new innovations in HLA typing and histocompatibility at ASHI.

IVDR Product Certifications

The IVDR replaces IVDD as the European Union’s updated regulatory framework for in vitro diagnostic medical devices. IVDR certified products—such as AlloSeq Tx and QTYPE—meet the highest standards for diagnostic reliability and regulatory compliance, ensuring greater transparency and trust for clinical laboratories across Europe. The IVDR approvals come in advance of the European regulatory deadline of December 2027 for HLA-typing devices.

About CareDx

CareDx, Inc., headquartered in Brisbane, California, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, 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, expected launch timing of CareDx products, 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; risks that CareDx products may not launch on the expecting timing or at all; general economic and market factors; and other risks discussed in CareDx’s filings with 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, 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.

AlloSeq Tx and QTYPE are available as CE-IVD and Research Use Only (RUO). RUO products are not to be used for diagnostic procedures. For local regulatory status, please contact CareDx. AlloSeq is a trademark or registered trademark of CareDx Inc. or its subsidiaries in the US or other countries. AlloSeq is a registered trademark with the US Patent and Trademark Office. © 2025 CareDx, Inc. All service marks or trademarks are owned or licensed by CareDx, Inc. or its affiliates. All rights reserved