Summary: Universal DX initiated a clinical trial for its Signal-C colorectal cancer screening blood test, funded by a Series B round, with the goal of achieving FDA premarket approval and offering a non-invasive, accurate early detection method.
Takeaways:
- Clinical Trial Launch: Universal DX’s Signal-C test, aimed at early colorectal cancer detection, is undergoing a large-scale clinical trial, with a target enrollment of 15,000 patients across 100 sites.
- Collaborative Effort: In collaboration with Quest Diagnostics, which will provide clinical laboratory services pending FDA approval, Universal DX is working towards commercializing this innovative screening test.
- Significant Public Health Potential: The Signal-C test, using next-generation sequencing and bioinformatics, could increase colorectal cancer screening rates and significantly reduce mortality by enabling earlier, non-invasive detection.
Universal DX, a biotech company dedicated to transforming cancer into a curable disease by detecting it early, announced closure of the Series B which funds the clinical trial for its colorectal cancer screening blood test, Signal-C, aimed at achieving FDA premarket approval.
The Signal-C Colorectal Cancer Screening Blood Test
The clinical trial for Signal-C is under way and recruited its first patient in January 2024. The study is on target to reach its recruiting goal of enrolling at least 15,000 patients across 100 investigator sites.
Quest Diagnostics operates an oncology center of excellence in Lewisville, Texas, that will serve as the single site for testing for the trial. The parties announced a collaboration in November 2023 under which Quest will have exclusive rights to provide clinical laboratory services in the U.S. assuming FDA approval for the test. UDX is the provider of the results of the assay through its proprietary cloud solution. Once FDA approved, both parties will commercialize the test.
“We are thrilled to announce the start of our FDA validation for Signal-C,” says Juan Martinez-Barea, Chairman of UDX. “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.”
Signal-C uses next-generation sequencing (NGS) and bioinformatics to identify methylated DNA patterns and fragments shed by colorectal cancer tumors circulating in the bloodstream. The UDX Signal-C test has repeatedly demonstrated high accuracy as shown in studies presented at ASCO GI 2023 and Digestive Disease Week 2023.
Impact of Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in both men and women in the U.S. In 2023, an estimated 153,020 people were diagnosed with colorectal cancer in the U.S., and 52,550 died from the disease, according to the American Cancer Society. Screening can help detect the disease in its early, more treatable stages.
However, according to a 2021 National Health Interview Survey, only 59% of individuals aged 45 years and older were up to date on colorectal cancer screening mainly due to relatively low compliance rates of existing screening techniques. It is expected that simple and non-intrusive blood tests will significantly increase the percentage of individuals screened, reduce the mortality rate and, consequently, help save more lives.
Further reading: Hot Spots to Improve Colorectal Cancer Screening in Hispanic/Latino Communities Identified
