CareDx Unveils New IVDR-Certified Transplant Diagnostics and Advanced HLA Typing Technologies at ASHI 2025
CareDx, Inc. widely recognized as The Transplant Company™ — announced a major wave of product innovations and regulatory milestones during the American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, taking place from October 6–10 in Orlando, Florida. The precision medicine leader, long known for its deep expertise in transplant diagnostics, used the global forum to debut several new technologies that strengthen its position in both solid organ and stem cell transplantation diagnostics. Among the key announcements was the certification of AlloSeq® Tx and QTYPE® under the In Vitro Diagnostic Regulation (IVDR) in the European Union — a pivotal regulatory achievement that underscores CareDx’s commitment to quality, compliance, and clinical excellence.
Strengthening a Legacy of Innovation in Transplant Diagnostics
“For over two decades, CareDx has been deeply committed to transforming transplant care through molecular innovation,” said John Hanna, President and Chief Executive Officer of CareDx. “At ASHI 2025, we’re highlighting the latest advances that not only reflect our sustained investment in research and product development, but also reaffirm our mission to help transplant patients live longer and healthier lives. The new products we’re introducing, together with our IVDR certifications, signal the next chapter in precision transplantation diagnostics.”
CareDx’s participation at ASHI 2025 is anchored in three key themes: advancing HLA typing technology, integrating genomic insight into donor-recipient matching, and aligning global product portfolios with evolving regulatory standards. The company’s comprehensive exhibit and sponsored sessions are attracting considerable attention from laboratory professionals, clinicians, and transplant researchers across the globe.
Next-Generation Product Launches and Technology Showcase
CareDx’s portfolio expansion at ASHI 2025 includes the launch of AlloSeq Tx11, a next-generation HLA typing solution, the rollout of an upgraded SCORE 7 software platform for QTYPE, and an introduction to a novel long-read genotyping assay offered under an Early Access Program. Collectively, these products demonstrate the company’s focus on improving diagnostic speed, precision, and accessibility in transplant medicine.
AlloSeq Tx11: Expanding the Boundaries of Compatibility Assessment
One of the central highlights of the conference is AlloSeq Tx11, the newest evolution of CareDx’s flagship next-generation sequencing (NGS)–based typing platform. Designed to provide enhanced Class II HLA coverage, the technology enables more precise donor-recipient matching, which is critical for improving graft survival and reducing post-transplant complications.
Beyond traditional HLA markers, AlloSeq Tx11 now incorporates non-HLA genetic markers such as ABO, CCR5, LIMS1, and APOL1. These additions allow for a broader and more nuanced assessment of transplant risk, taking into account emerging genetic insights linked to immune response and allograft outcomes. The system is built to perform robustly even with low-quality DNA samples, reducing the likelihood of allele dropout and minimizing the need for retesting. Laboratories can also benefit from flexible sample pooling, enabling efficient throughput and cost savings.
The upgraded platform reflects CareDx’s continuing leadership in NGS-based solutions and its role in shaping the next generation of precision transplant diagnostics.
SCORE 7 Software: Future-Ready Analysis for Rapid Typing Workflows
Complementing its HLA typing innovations, CareDx introduced SCORE 7, the modernized software interface designed to enhance analytical workflows for the company’s QTYPE® system.
QTYPE, a real-time PCR–based solution for low-to-intermediate resolution HLA typing, is used widely in laboratories seeking rapid, reliable results for donor-recipient matching. The new SCORE 7 platform brings improved scalability, seamless user experience, and full readiness for future ABO typing integration. Importantly, it has been developed to maintain alignment with IVDR regulatory requirements, ensuring its continued applicability in the European market.
The software upgrade represents not just a technical enhancement but a strategic move toward harmonizing CareDx’s global software infrastructure — enabling laboratories to manage high data volumes, standardize workflows, and prepare for multi-marker typing in a single, unified system.
Early Access: A Breakthrough Long-Read HLA Typing Assay
Among the most talked-about previews at ASHI 2025 is CareDx’s long-read-based HLA typing technology, which promises to redefine genotyping speed and accuracy. Available under an Early Access Program, the assay provides same-day turnaround and supports flexible throughput, making it adaptable for both research and clinical environments.
At the heart of this technology is a novel probe design engineered to reduce allele dropout and improve robustness across a wide range of sample qualities. The system’s long-read sequencing approach provides a comprehensive view of full-length HLA alleles, potentially resolving ambiguities that have long challenged existing short-read methods.
If successfully commercialized, this assay could represent a paradigm shift in histocompatibility testing — dramatically shortening testing cycles and enabling transplant centers to make faster, data-driven matching decisions.
Scientific Presentation: Integrating ABO and HLA Genotyping for Precision Matching
A highlight of CareDx’s scientific presence at ASHI 2025 is the poster presentation titled “Rapid ABO Genotyping Assay in Combination with HLA Genotyping.” This work, conducted across three clinical sites, demonstrates the successful validation of a new molecular assay for ABO blood group determination that integrates seamlessly into HLA genotyping workflows.
The study achieved 100% concordance between the rapid QTYPE ABO assay and established molecular methods in both genotype and phenotype determination. This finding reinforces the assay’s clinical reliability and its potential to improve organ allocation efficiency.
The research underscores the critical importance of accurate ABO typing, particularly in identifying subgroups such as A2, which can expand donor eligibility and facilitate ABO-incompatible transplant programs. By combining ABO and HLA genotyping into a unified qPCR-based workflow, CareDx’s new approach can offer:
- Faster turnaround times, enabling rapid pre-transplant decision-making
- Lower operational costs through workflow consolidation
- Reduced reagent and labor requirements
- Greater consistency across laboratory settings
For transplant centers that handle complex or mismatched donor-recipient cases, such integrated typing technologies could lead to both operational efficiency and improved patient outcomes.
Educational and Collaborative Session: Addressing Unmet Needs in ABO Typing
As part of its leadership role in advancing transplant diagnostics, CareDx is also hosting a User Group Meeting at ASHI 2025, titled “ABO Histocompatibility in Transplantation: Current Status, Unmet Needs, and Future Directions.”
This sponsored session brings together renowned experts from Brigham and Women’s Hospital, LifeLink Foundation, and the University of Alberta, who will explore the latest insights into ABO typing and its role in graft success. Topics include:
- The clinical significance of ABO antibodies in transplant rejection
- Understanding genotype vs. phenotype discrepancies and how new technologies can resolve them
- The contribution of fucosyltransferase genes and Exon 1 analysis in enhancing ABO typing precision
- Ongoing international standardization efforts to unify ABO compatibility testing across regions
Through this session, CareDx aims to foster collaboration among researchers, clinicians, and laboratory professionals — supporting the global effort to refine histocompatibility assessment and improve transplant outcomes.
Regulatory Milestone: IVDR Certification for AlloSeq Tx and QTYPE
Beyond its scientific presentations and product showcases, CareDx’s announcement of IVDR certification for AlloSeq Tx and QTYPE stands as one of the company’s most impactful achievements of the year.
The In Vitro Diagnostic Regulation (IVDR) is the European Union’s updated framework that replaces the previous In Vitro Diagnostic Directive (IVDD), introducing more stringent requirements for clinical evidence, performance evaluation, and post-market surveillance. Products that meet IVDR standards must demonstrate the highest levels of diagnostic reliability, transparency, and quality assurance.
By achieving IVDR certification well ahead of the December 2027 regulatory deadline for HLA-typing devices, CareDx reinforces its commitment to compliance and patient safety. This milestone ensures that European clinical laboratories can continue to rely on AlloSeq and QTYPE for mission-critical transplantation testing under the new regulatory environment.
The certification also highlights the company’s proactive approach to global quality systems and underscores its reputation as a trusted partner to laboratories worldwide. For CareDx, regulatory excellence is not merely an obligation — it is a core pillar of its mission to deliver accurate, timely, and actionable data to the transplant community.
Advancing the Future of Transplant Precision Medicine
CareDx’s comprehensive portfolio — spanning pre-transplant diagnostics, post-transplant monitoring, and digital health solutions — positions the company uniquely at the intersection of genomics and clinical care. With its new product launches and IVDR-certified diagnostics, CareDx is setting the foundation for a new era of precision transplantation that combines molecular insight, regulatory rigor, and operational efficiency.
As the global demand for organ transplantation grows, so does the need for faster, more reliable, and more informative diagnostic tools. The innovations unveiled at ASHI 2025 not only address these demands but also point toward a future where data-driven compatibility assessment and integrated molecular testing become standard practice in transplant medicine.
“Our focus remains clear — empowering transplant professionals with the tools they need to make informed decisions and deliver optimal patient outcomes,” said Hanna. “Every product we develop, every certification we achieve, and every collaboration we build is guided by that singular purpose.”
With its robust pipeline, regulatory foresight, and expanding global footprint, CareDx continues to lead the evolution of transplant diagnostics — ensuring that each innovation brings patients one step closer to a longer, healthier life post-transplant.
