Sanbio, in collaboration with CareDx, Inc., is thrilled to announce the publication of a groundbreaking paper titled "Multi-centre analytical performance verification of an IVD assay to quantify donor-derived cell-free DNA in solid organ transplant recipients" in HLA journal, now accessible in open access.

This significant research underscores the remarkable concordance of results among users of donor-derived cell-free DNA (dd-cfDNA), both within and across laboratories, utilizing the AlloSeq cfDNA decentralized test. We invite you to explore the profound implications of this study for advancing transplant care.

The primary author, Sílvia Casas, Senior Medical Director, EMEA at CareDx, Inc., spearheaded this pivotal research. Excitingly, Sílvia will be present at the forthcoming 37th EFI Conference in Geneva, accompanied by Sanbio's CCO Barry Leenders and account manager Tom van Iersel. We encourage interested parties to connect with us to arrange meetings or address inquiries directly with Sílvia and the team.

ABSTRACT

Donor-derived cell-free DNA (dd-cfDNA) has been widely studied as biomarker for non-invasive allograft rejection monitoring. Earlier rejection detection enables more prompt diagnosis and intervention, ultimately improving patient treatment and outcomes. This multi-centre study aims to verify analytical performance of a next-generation sequencing-based dd-cfDNA assay at end-user environments. Three independent laboratories received the same experimental design and 16 blinded samples to perform cfDNA extraction and the dd-cfDNA assay workflow. dd-cfDNA results were compared between sites and against manufacturer validation to evaluate concordance, reproducibility, repeatability and verify analytical performance.