Universal DX (UDX) has closed its Series B funding round, securing capital to advance the clinical trial of Signal-C, a colorectal cancer screening blood test.
The funding round saw participation from existing investors including Quest Diagnostics, and new investors including Olympus Innovation Ventures.
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The trial aims to secure US FDA premarket approval for Signal-C.
Universal DX started the clinical trial for Signal-C test and began enrolling patients in January 2024. It is on track to meet its recruitment target of at least 15,000 participants across 100 investigator sites.
This large-scale study is a crucial step in validating the test’s efficacy and safety for FDA review.
Quest Diagnostics’s oncology centre of excellence in Lewisville, Texas, will be the only testing site for the trial.
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By GlobalDataThe collaboration between Quest Diagnostics and Universal DX, established in November 2023, grants the former exclusive rights to provide clinical laboratory services in the US, assuming approval from the FDA for the test.
Using next-generation sequencing (NGS) and bioinformatics, the Signal-C test can detect methylated DNA patterns and fragments in the bloodstream that are indicative of colorectal cancer tumours.
UDX chairman Juan Martinez-Barea said: “We are thrilled to announce the start of our FDA validation for Signal-C.
“After securing the funding required, and having operationally launched our collaboration with Quest, UDX is one step closer to reaching the market with a non-invasive, highly accurate blood test for screening for colorectal cancer. Early detection is crucial, and our technology has the potential to significantly reduce the mortality of this disease.”
Upon the FDA approval, Universal DX and Quest Diagnostics will jointly commercialise Signal-C.
Universal DX will deliver assay results through its proprietary cloud solution, facilitating a streamlined process for clinicians and patients.
Last month, Quest Diagnostics signed an agreement to buy Canada-based laboratory tests provider LifeLabs for approximately C$1.35bn ($985m).
