Universal DX (UDX) and Quest Diagnostics have entered into a commercial agreement to advance colorectal cancer screening in the US with a new blood test. Here are the key points from the article:
- The Signal-C Test: The test, named Signal-C, utilizes next-generation sequencing (NGS) and bioinformatics to detect methylated DNA patterns and fragments shed by colorectal cancer tumors circulating in the bloodstream. This innovative approach aims to improve the detection and screening of colorectal cancer.
- Clinical Study for FDA Approval: UDX is conducting a large-scale study involving 15,000 patients across more than 100 investigator sites to gather clinical evidence for the Signal-C test. This study is a crucial step in seeking premarket approval from the US Food and Drug Administration (FDA).
- Role of Quest Diagnostics: Upon FDA approval, Quest Diagnostics plans to offer clinical laboratory services using the Signal-C test. Quest’s oncology center of excellence in Lewisville, Texas, will be the single site for conducting tests related to the study. Quest will also hold exclusive rights to offer these clinical laboratory services in the US.
The collaboration between UDX and Quest Diagnostics represents a significant advancement in colorectal cancer screening, potentially offering a more convenient and accessible option for early detection. This could lead to earlier treatment and better outcomes for patients.