공시 • Dec 03
Oncocyte Corp. Announces Additional Favorable Data Regarding Its Lead Assay Vitagraft™?
Oncocyte Corp. announced additional favorable data regarding its lead assay VitaGraft™?, which was published in the journal, Nephrology Dialysis Transplantation. VitaGraft Kidney™? quantifies the amount of DNA fragments in transplant patients' blood that originate from the donor organ, a key biomarker for assessing graft health. This process is commonly referred to as donor-derived cell-free DNA (dd-cfDNA) testing and is widely used in clinical practice today. In this latest study, Oncocyte's proprietary diagnostic dd-cfDNA test using digital PCR was able to diagnose antibody-mediated rejection (AMR) in kidney transplant recipients nearly a year ahead of standard protocols. For further context, de-novo donor specific antibody (dnDSA) is a routine biomarker used in kidney transplant management. The appearance of dnDSA in a patient -- that is, the patient is found to be dnDSA-positive (dnDSA+) -- signals an increased risk of AMR. This latest study shows that compared to standard of care, VitaGraft Kidney can significantly reduce the time to diagnosis of AMR in dnDSA+ patients. It is also the first randomized interventional study to validate any dd-cfDNA technology as a rule-in test for biopsy in a high-risk population. Catching AMR early, when kidney graft loss can be minimized, is becoming increasingly important as physicians explore the use of drugs, including the anti-CD38 drugs felzartamab and daratumumab, to manage rejection. Monitoring with VitaGraft in this high-risk patient population could support early intervention with these new therapeutic options. Once patients are on therapy, monitoring for therapeutic efficacy is also important to manage potential unwanted side effects. Publications using VitaGraft to monitor for efficacy for both aforementioned drugs can be found in the New England Journal of Medicine and Transplant International. In addition, earlier this year, Oncocyte signed an agreement with a European biotechnology company to be the provider of dd-cfDNA testing for a Phase II clinical trial for a separate therapeutic in AMR. Oncocyte expects to submit for claims expansion to its payor, MolDX2, to support the use of VitaGraft for these high-risk patients in the clinic. If granted, it would expand the use case beyond the current for-cause claim, opening significant new revenue opportunities. In sum, this clinical trial provides compelling evidence for dd-cfDNA monitoring as a tool for enhancing early intervention and improving outcomes for patients at increased risk of transplant rejection. Oncocyte scientists and inventors of the technology, Dr. Schuetz, Julia Beck and Kirsten Bornemann-Kolatzki, co-authored the study, which was initiated by researchers at Charité – Universitätsmedizin Berlin under the leadership of Prof. Klemens Budde. The interventional randomized trial, conducted between June 2021 and July 2023, involved 40 kidney transplant recipients with dnDSA, assessing longitudinal dd-cfDNA monitoring as a guiding tool for diagnostic biopsy compared to standard clinical practices. Oncocyte’s proprietary dd-cfDNA technology was able to detect the onset of AMR significantly earlier in patients by guiding the indication for biopsy (median time from inclusion to diagnosis: 2.8 months) compared to the control group using standard of care (14.5 months). As noted above, this early intervention could offer a valuable advantage in transplant care by enabling prompt treatment before irreversible damage occurs. This study also suggests that dd-cfDNA monitoring could also be instrumental in identifying subclinical AMR—a silent condition that, if undiagnosed, can lead to significant graft damage. Additionally, the findings come at a crucial time, as mentioned above, as promising new treatments, including CD38-targeted therapies, are showing unprecedented efficacy in treating AMR. Early diagnosis with dd-cfDNA could provide the earliest window for intervention, offering an advantage for patients suffering from AMR, a disease with historically very limited treatment options.