IRVINE, Calif. - Oncocyte Corp. (NASDAQ: OCX), a diagnostics company with a market capitalization of $39.56 million, revealed research indicating its DetermaCNI™ assay could be a non-invasive method for diagnosing central nervous system tumors. The study, published in Acta Neuropathologica Communications, showed the assay's effectiveness in detecting somatic copy number aberrations (SCNAs) in cerebrospinal fluid, a significant cancer hallmark.
The current approach to diagnosing brain tumors typically involves invasive biopsies, posing risks and often requiring the sampling of brain tissue. DetermaCNI™ offers a liquid biopsy alternative, potentially impacting the roughly 300,000 U.S. patients annually diagnosed with primary brain tumors or metastasis. This could represent a $300 million market opportunity in the U.S. alone. According to InvestingPro data, the company currently generates $0.71 million in trailing twelve-month revenue, suggesting significant growth potential in this market.
The proof of principle study, which included contributions from Oncocyte Chief Science Officer Ekke Schuetz and Senior R&D Director Julia Beck, assessed the measurement of copy number instability in cerebrospinal fluid from patients with brain cancer. SCNAs were found in the fluid of 10 out of 12 patients with confirmed central nervous system cancers, but not in any of the 11 patients with benign or unclear lesions, indicating the method's specificity for tumor-derived cell-free DNA.
According to Dr. Schuetz, the findings suggest that DetermaCNI could benefit a significant number of patients, offering a safer and less invasive diagnostic alternative. The company views this study as validation for DetermaCNI's clinical potential and a positive direction for Oncocyte's research and development efforts. InvestingPro analysis reveals the company is currently investing heavily in development, with an EBITDA of -$21.56 million in the last twelve months. For deeper insights into Oncocyte's financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
Oncocyte is currently commercializing its transplant product line, including VitaGraft™ and GraftAssure™ tests, and plans to bring its oncology assays to market within the next two years. The company's mission is to democratize access to molecular diagnostic testing to improve patient outcomes.
The information reported is based on a press release statement from Oncocyte Corp. and the study's publication details. The study's implications suggest that DetermaCNI™ could become an important tool in the diagnosis and management of central nervous system cancers. Based on InvestingPro's Fair Value analysis, the stock appears fairly valued, with analysts setting price targets ranging from $4.00 to $4.25, suggesting potential upside from current levels.
In other recent news, OncoCyte (NASDAQ:OCX) Corporation has made significant strides in the transplant diagnostics market with the successful launch of its GraftAssure RUO product. The product, co-marketed with Bio-Rad, is reportedly performing well, and the company is actively engaging transplant centers in preparation for its upcoming VitaGraft Kidney kitted test, anticipated to launch in the fourth quarter of 2025, pending FDA approval. OncoCyte's strategy involves securing agreements with at least 20 transplant centers across the United States and Germany by the end of 2025.
Recent developments also include a successful capital raise of about $9 million in October 2024, bolstering the company's pro forma cash reserves to approximately $15 million. The company's financial discipline is reflected in its efforts to maintain its quarterly cash burn rate at roughly $6 million.
OncoCyte recently outlined its growth strategy during its Q3 2024 earnings call, revealing plans to expand its transplant testing services. The company raised $10.2 million to support these initiatives and expressed confidence in the potential of its oncology product, DetermaIO. It is targeting to sign 20 sites by the end of 2025, projecting an annual revenue of $1 million per site.
Analysts from Needham maintained their Buy rating for OncoCyte, following the positive developments with the GraftAssure RUO product. They also highlighted the role of Bio-Rad in providing access to OncoCyte's RUO product and building relationships with transplant centers.
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