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

Original from: CareDx

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.

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