Universal DX (UDX) has completed its Series B funding round, which will support the clinical trial for its colorectal cancer screening blood test, Signal-C®. This trial is a key step toward securing FDA premarket approval and advancing the company’s mission to transform cancer into a curable disease through early detection.
The Signal-C® clinical trial is progressing, having enrolled its first patient in January 2024 and aiming to recruit 15,000 participants across 100 sites. Quest Diagnostics’ oncology center in Lewisville, Texas, will handle testing for the trial. Under a November 2023 agreement, Quest will exclusively provide clinical laboratory services in the U.S. if the test receives FDA approval, while UDX will deliver results via its proprietary cloud platform. Both companies will commercialize the test upon approval.
Juan Martinez-Barea, Chairman of UDX, expressed excitement about advancing Signal-C® towards FDA validation. He highlighted the test’s potential to improve early detection and reduce colorectal cancer mortality. Signal-C® employs next-generation sequencing and bioinformatics to identify cancer-related DNA patterns in the bloodstream, with high accuracy demonstrated in recent studies.
Colorectal cancer is a major health concern, ranking as the third most common cancer and cause of cancer death in the U.S. Screening rates are currently low, but non-invasive blood tests like Signal-C® could increase compliance and save lives.
About Universal DX
Universal DX, headquartered in Spain with a U.S. office in Cambridge, focuses on early cancer detection through advanced multi-omics, computational biology, and AI. The company’s technology targets colorectal cancer and holds promise for other high-burden cancers.
