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Oncocyte Corp. Research Sheds Light on Non-Invasive Tumor Diagnostics
IRVINE, Calif. – Oncocyte Corp. (NASDAQ: OCX), a diagnostics firm valued at approximately $39.56 million, has unveiled research suggesting its DetermaCNI assay could serve as a non-invasive diagnostic method for central nervous system (CNS) tumors. Findings from a study published in Acta Neuropathologica Communications highlight the assay’s capability in identifying somatic copy number aberrations (SCNAs) within cerebrospinal fluid, a notable indicator in cancer diagnostics.
Traditionally, diagnosing brain tumors involves invasive biopsy procedures, which carry certain risks and require the extraction of brain tissue. The DetermaCNI assay provides a liquid biopsy alternative, potentially transforming the diagnostic landscape for an estimated 300,000 patients in the U.S. diagnosed annually with either primary brain tumors or metastatic conditions. This shift could represent a market opportunity valued at around $300 million in the United States. According to data from InvestingPro, Oncocyte currently records trailing twelve-month revenues of approximately $0.71 million, indicating substantial room for growth in this emerging market.
The proof of principle study, co-conducted by Oncocyte’s Chief Science Officer Ekke Schuetz and Senior R&D Director Julia Beck, focused on assessing copy number instability in cerebrospinal fluid from brain cancer patients. The research found SCNAs present in the cerebrospinal fluid of 10 out of 12 patients diagnosed with CNS cancers, while no such aberrations were detected in 11 patients with benign or indeterminate lesions. This finding underscores the assay’s specificity for detecting tumor-derived cell-free DNA.
Dr. Schuetz commented on the implications of the findings, suggesting that DetermaCNI could offer significant advantages by providing a safer and less invasive diagnostic option for a large patient population. The study is regarded by the company as a validation of DetermaCNI’s clinical utility and as a promising step forward for Oncocyte’s ongoing research and development initiatives. Current analysis from InvestingPro indicates that while the company is heavily investing in future developments, it faces a negative EBITDA of -$21.56 million over the past year. For investors interested in more detailed insights regarding Oncocyte’s financial positioning and growth trajectory, comprehensive reports are available through InvestingPro.
Oncocyte is also in the process of commercializing its transplant diagnostic offerings, which include the VitaGraft and GraftAssure tests. The company aims to introduce its oncology assays to the market in the next two years, aligning with its mission of increasing accessibility to molecular diagnostics to enhance patient outcomes.
The recent report highlights the potential for the DetermaCNI assay to emerge as a vital instrument in diagnosing and managing CNS cancers. Based on InvestingPro’s Fair Value analysis, the stock is deemed fairly valued, with analysts projecting price targets between $4.00 and $4.25, indicating notable upside potential from its current market position.
In related news, OncoCyte has made significant advancements in the transplant diagnostics sector with the recent launch of its GraftAssure RUO product. This product, co-marketed with Bio-Rad, has reportedly performed well, and the company is actively establishing partnerships with transplant centers ahead of the anticipated release of its VitaGraft Kidney kitted test, expected in Q4 2025 pending FDA approval. OncoCyte aims to secure agreements with at least 20 transplant centers in both the U.S. and Germany by the end of 2025.
Additionally, the company recently completed a successful capital raise of approximately $9 million in October 2024, which bolsters its pro forma cash reserves to about $15 million. OncoCyte’s fiscal strategies reflect a commitment to maintaining a quarterly cash burn rate of around $6 million.
During its Q3 2024 earnings call, OncoCyte outlined its ambitious growth strategy, including plans to expand its transplant testing services. The company secured $10.2 million to fund these initiatives while expressing optimism regarding its oncology product, DetermaIO. The goal is to contract 20 sites by the end of 2025, with projections suggesting an annual revenue generation of $1 million per site.
Analysts at Needham have reiterated their Buy rating for OncoCyte, citing recent positive developments associated with the GraftAssure RUO product. They acknowledged Bio-Rad’s critical role in facilitating connections between OncoCyte and transplant centers.
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