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Oncocyte's Proprietary Assay Demonstrates Long-Term Clinical Validity
GlobeNewswire News Room· 2025-04-29 12:30
Core Viewpoint - Oncocyte Corp. has published new data on its blood-based transplant rejection assay, indicating significant advancements in understanding organ rejection and potential market expansion opportunities for monitoring high-risk patients [1][4]. Scientific Significance - The study demonstrates a correlation between microvascular and vascular inflammation and elevated donor-derived cell-free DNA (dd-cfDNA) levels in blood plasma, enhancing the understanding of organ rejection biology [2]. - Two novel observations were made: T-cell mediated rejection (TCMR) is linked to high dd-cfDNA levels in the presence of vascular inflammation, while calcineurin inhibitor toxicity does not elevate dd-cfDNA levels [7][8]. Strategic Significance - The research supports the long-term management of high-risk transplant patients using Oncocyte's proprietary test, which is positioned to disrupt the market with more affordable and faster testing options [4][5]. - The study's findings validate the clinical utility of dd-cfDNA testing over a decade post-transplant, indicating its relevance in ongoing patient management [5]. - A significant portion of patients with organ rejection also exhibited de novo donor-specific antibodies, aligning with Oncocyte's previous clinical trial findings that led to expanded Medicare reimbursement [6]. Market Expansion - Oncocyte is developing a kitted version of its assay for local lab use, aiming to enhance accessibility and affordability of transplant monitoring tests [3]. - The collaboration with Charité University in Berlin has been instrumental in advancing scientific knowledge in transplantation, further solidifying Oncocyte's position in the market [4].