Universal DX ("UDX") announced a strategic collaboration with Quest Diagnostics designed to improve colorectal cancer screening in the United States.
Under the commercial agreement between UDX and Quest, Quest plans to perform and provide clinical laboratory services to providers and patients in the United States based on UDX's Signal-C, an advanced colorectal cancer screening blood test, assuming premarket approval of the test in the United States.
To support a submission to the U.S. Food and Drug Administration for premarket approval, UDX will enroll patients in a 15,000-patient study involving more than 100 investigator sites to develop clinical evidence for the test. Quest's oncology center of excellence in Lewisville, TX, will serve as the single site to support testing for the study. Assuming FDA approval, Quest will have exclusive rights to provide clinical laboratory services in the U.S.
UDX also announced the initial closing of its series B financing of approximately $70 million from investors, including Quest Diagnostics.
The collaboration aims to combine UDX's innovative liquid biopsy screening technology with Quest's expertise and national scale in the United States, which includes broad electronic health record connectivity and health plan relationships as well as approximately 2,100 patient service centers for blood draws.
Signal-C uses next generation sequencing (NGS) and bioinformatics to identify methylated DNA patterns and fragments shed by colorectal cancer tumors circulating in the blood stream. In a 1,000-patient study presented at Digestive Disease Week in May 2023, Signal-C demonstrated 93% sensitivity for colorectal cancer detection, and 54% sensitivity for detection of precancerous lesions (called advanced adenomas) at 92% specificity overall. The ability to identify advanced adenomas in the precancerous stage may help reduce colorectal cancer incidence and mortality.