Core Insights - Oncocyte Corporation announced favorable data for its product VitaGraft™ Kidney, published in the New England Journal of Medicine, indicating its potential in monitoring graft injury and therapeutic efficacy in kidney transplant patients [1][2] - The study demonstrated that VitaGraft Kidney can identify responders to the investigational drug felzartamab, showing significant reductions in donor-derived cell-free DNA (dd-cfDNA) at weeks 12 and 24 [2][3] - The results suggest new clinical applications for VitaGraft Kidney, including monitoring therapeutic efficacy and recurrence of antibody-mediated rejection (AMR) [2][3] Company Overview - Oncocyte is a precision diagnostics company focused on providing clarity and confidence to physicians and patients through its diagnostic tests [6] - The company’s products include VitaGraft™ for solid organ transplantation monitoring and GraftAssure™, a research-use-only test [6] - Oncocyte's technology aims to improve care and outcomes for high-risk kidney transplant patients suffering from AMR [4] Clinical Study Insights - The phase 2 trial indicated that monitoring dd-cfDNA could effectively detect responsiveness to felzartamab therapy and uncover disease recurrence after treatment cessation [3] - Up to 20.2% of kidney transplant patients may develop AMR within 10 years, with a significant percentage progressing to graft failure [3][7] - There are currently no FDA-approved drugs for managing AMR, highlighting a critical unmet need in transplant management [3] Future Prospects - Oncocyte's CEO expressed optimism about the study's potential to lead to new treatment options for kidney transplant patients globally [4] - The partnership with Bio-Rad is expected to enhance the scale and adoption of dd-cfDNA monitoring tools in the transplant research community [4] - The results will be presented at the 2024 American Transplant Congress, indicating ongoing engagement with the medical community [4][5]
Favorable Oncocyte VitaGraft Kidney Study Results Published in the New England Journal of Medicine