Oncocyte(US:OCX) Globenewswire·2025-03-24 20:05Core Insights - Oncocyte Corp. is progressing towards launching a regulated organ transplant rejection monitoring test kit, expected to generate significant revenue in the coming years [1][10][22] - The company aims to capture a share of the estimated $1 billion market for transplant rejection testing, with a focus on commercializing its GraftAssure research-use-only test kit [1][15][22] Company Developments - In 2025, Oncocyte plans to announce advancements in its multi-center clinical trial for the clinical test kit and expand sales of the GraftAssure RUO test kit [2][3] - The company has signed a strategic partnership with Bio-Rad Laboratories, which has invested approximately 9.66% of Oncocyte's outstanding shares [5][17] - Oncocyte's clinical trial will take place at leading transplant centers in the U.S. and Europe, reflecting strong interest from these institutions [4][8] Financial Overview - Q4 2024 revenue was reported at $1.5 million, with a full-year revenue of $1.9 million, primarily from pharma services [5][26] - The company achieved a gross profit of $595,000 in Q4 2024, representing a 40% gross margin [26] - Operating expenses for Q4 2024 totaled $34.2 million, influenced by non-cash impairment losses [26][27] Regulatory and Market Position - Oncocyte is targeting FDA submission for its kitted product by the end of 2025, with authorization expected in 2026 [8][18] - The company aims to democratize access to transplant rejection tests, allowing hospitals to conduct tests in-house [6][7] - Medicare coverage for Oncocyte's assay has expanded, highlighting its clinical significance in early detection of transplant rejection [16] Future Outlook - The company anticipates that localized, real-time monitoring will become the standard of care by 2028, positioning itself to capture a significant market share [22][23] - Oncocyte is focused on enhancing its product based on feedback from leading transplant centers, which will aid in driving adoption [9][25]