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Key Highlights:
- Oncocyte partners with top transplant hospitals in the U.S. and Germany for GraftAssure™.
- The Company aims for FDA clearance for clinical use of its dd-cfDNA kitted test.
- Strong demand for GraftAssure exceeds expectations, bolstered by strategic partnership with Bio-Rad.
Oncocyte Corporation (Nasdaq:OCX), a leading diagnostics technology company, has announced a significant step forward in its commercial strategy. The Company has secured agreements with two prominent transplant university hospitals—one in the U.S. and another in Germany—to utilize its GraftAssure™ assay. This innovative research-use-only assay can detect early signs of graft organ damage through analysis of donor-derived cell-free DNA (dd-cfDNA) present in patients' blood, marking a crucial advancement in transplant diagnostics.
This development is pivotal for Oncocyte as it endeavors to commercialize its intellectual property in the organ transplant sector. The Company’s strategy involves creating a kitted test based on dd-cfDNA biomarkers, positioning GraftAssure as a cornerstone product in a projected $1 billion transplant market. By collaborating with leading transplant centers and research institutions, Oncocyte aims to drive the commercial adoption of its molecular diagnostic tests while capturing market share. Although GraftAssure is currently classified as a research tool, the Company is working towards obtaining FDA clearance for clinical applications.
Joshua Riggs, CEO of Oncocyte, expressed enthusiasm about the market's response to GraftAssure. He stated, “The two institutions we have agreements with are top-five research hospitals in their countries, and they share our vision of democratizing access to this technology.” This sentiment underscores the importance of strategic partnerships in advancing the Company’s mission to improve patient outcomes in organ transplantation.
In addition to these agreements, Oncocyte is on track with its plans to submit an in-vitro diagnostic (IVD) version of its dd-cfDNA kitted test to the FDA. The Company has initiated the Q-submission process, with a formal meeting scheduled with the FDA in early December. This step is critical for receiving written feedback on their development plan, which will enhance the validation process slated to begin in early 2025.
Oncocyte's proactive approach has led to heightened interest in its transplant assay, surpassing management's expectations. Following earlier reports of GraftAssure's successful utilization at a major transplant center in the northeast U.S. and a lab in Southeast Asia, the new partnerships indicate strong market traction. The Company continues to establish a committed customer base that supports future revenue growth.
The strategic partnership with Bio-Rad Laboratories, Inc., which was formed in April 2024, further solidifies Oncocyte's market position. Bio-Rad is co-marketing GraftAssure in the U.S. and Germany while retaining exclusive distribution rights outside these regions. This collaboration leverages Bio-Rad’s extensive global infrastructure, allowing Oncocyte to access high-end academic institutions effectively and enhance its sales efforts.
With fewer than 100 academic and research centers in the U.S. accounting for approximately 80% of transplant volumes, the market is highly concentrated. This concentration, along with Bio-Rad's capabilities, positions Oncocyte well to meet the needs of this specialized field. The Company is poised for significant growth as it advances its innovative solutions in transplant diagnostics, aiming to transform patient management and improve healthcare outcomes.
