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Universal DX Completes Series B Round to Launch Clinical Trial for Colorectal Cancer Screening Test

NextEdge Admin

16 Aug 2024

2 min 17 sec

colorectal cancer,next-generation sequencing

Spanish diagnostic firm Universal DX announced the successful closure of an extended Series B financing round, which will support the clinical trial necessary for obtaining US Food and Drug Administration (FDA) approval of its blood-based colorectal cancer screening test, Signal-C. The extension follows the initial $70 million Series B round disclosed in November, though the amount raised in this phase remains undisclosed. New investors, such as Olympus Innovation Ventures, joined existing supporters like Quest Diagnostics in this round.

Quest Diagnostics' oncology center in Lewisville, Texas, has been designated as the sole testing site for the clinical trial. If Signal-C secures FDA approval, both Universal DX and Quest Diagnostics will collaborate on the commercialization of the test. The trial, which began recruiting patients in January, is on track to enroll at least 15,000 participants across 100 investigator sites, according to a statement from Universal DX.

Signal-C utilizes next-generation sequencing and advanced bioinformatics to detect methylated DNA patterns and fragments released by colorectal cancer tumors into the bloodstream. Universal DX Chairman Juan Martinez-Barea highlighted the significance of this development, stating that the collaboration with Quest and the secured funding bring the company closer to introducing a noninvasive, highly accurate blood test for colorectal cancer screening. He emphasized the importance of early detection in reducing the mortality associated with colorectal cancer, expressing optimism about the potential impact of Signal-C on public health.