CareDx, Inc., the Transplant Company™ which is a major precision medicine company focused on the discovery, development, as well as commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, introduced 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.
Product Launches and Technology Previews at ASHI 2025 that will be featured are:
- 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.
- SCORE 7 Software: An advanced analysis application for QTYPE, manufactured for scalability and regulatory alignment, supporting future ABO typing and IVDR compliance. QTYPE is CareDx’s rapid HLA typing solution, manufactured 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.
Executive Statement
According to John Hanna, President and Chief Executive Officer, this week at ASHI 2025, they will highlight their continued investment in creating life changing solutions that allow transplant patients to thrive. The new product innovations and regulatory milestone underscore CareDx’s commitment to delivering high-quality HLA typing diagnostics and strengthens their position as the global leader of transplant solutions.