Oncocyte Expands Market Opportunity for VitaGraft™ Kidney

Core Insights - Oncocyte Corp. has achieved a significant milestone in advancing patient care for kidney transplant patients through the expansion of its VitaGraft Kidney test, which is now confirmed for monitoring patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR) [2][3][11] Group 1: Product Development and Market Expansion - The Molecular Diagnostics program (MolDX) has confirmed the use of VitaGraft Kidney for monitoring dnDSA+ patients, demonstrating its ability to detect AMR up to 11 months earlier than current standards [3][11] - Oncocyte aims to commercialize its proprietary diagnostic technology, which quantifies donor-derived cell-free DNA (dd-cfDNA), allowing local laboratories to run tests more affordably and quickly [5][8] - The expansion of Medicare coverage for VitaGraft Kidney under Local Coverage Determination (LCD) L38568 enhances the total addressable market for the assay, particularly for high-risk patients [6][11] Group 2: Clinical Significance and Impact - Early detection of AMR is critical, as up to 20% of kidney transplant patients may develop detectable DSA within five years, with a significant risk of allograft loss [10] - The test's ability to monitor anti-CD38 therapy is highlighted as a key feature, emphasizing the importance of early detection in the context of emerging therapeutic options [4][10] - The positive coverage decision from Palmetto GBA in August 2023 marks a pivotal step in the commercialization of the assay, confirming its eligibility for Medicare reimbursement [6][10]