Oncocyte Corporation announced positive data from a four-year study at Charité University in Berlin, validating its blood-based transplant rejection assay in 131 patients with 151 kidney biopsies. The study demonstrates the assay’s ability to identify rejection in patients up to 13 years post-transplant and correlates microvascular and vascular inflammation with elevated donor-derived cell-free DNA (dd-cfDNA). This reinforces the clinical utility of the assay for long-term monitoring, particularly in high-risk patients.
This research is crucial for advancing transplant care. The findings enhance the understanding of organ rejection biology by linking dd-cfDNA levels to specific histopathological patterns and Banff lesion scores. This more precise understanding of rejection mechanisms can potentially inform the development of targeted therapies and improve long-term graft survival. Furthermore, the study validates the assay’s effectiveness in long-term monitoring, supporting its use in managing high-risk patients, particularly those with donor-specific antibodies. This has significant implications for improving patient outcomes and optimizing immunosuppression strategies.
The study, published in Transplantation Direct, demonstrated the consistent clinical validity of Oncocyte’s assay over an extended period. It confirms the utility of dd-cfDNA testing even a decade after transplantation. Notably, a substantial portion of patients with confirmed rejection also possessed de novo donor-specific antibodies (dnDSA+), highlighting the assay’s relevance in monitoring this high-risk group. The study also revealed two novel findings: T-cell mediated rejection with vascular inflammation is linked to high dd-cfDNA elevation, while calcineurin inhibitor toxicity does not increase dd-cfDNA levels. This suggests dd-cfDNA as a specific biomarker for both antibody-mediated and T-cell mediated rejection with vascular inflammation.
This data reinforces the clinical value proposition of Oncocyte’s assay, supporting its potential for wider adoption in routine screening of high-risk transplant patients. Early detection of rejection, facilitated by this technology, becomes increasingly critical with the emergence of promising therapies like anti-CD38 treatments, which hold the potential to reverse or mitigate rejection episodes. This positions Oncocyte’s technology to play a pivotal role in the evolving landscape of transplant management.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
