Fecal DNA Testing for Colorectal Cancer Screening: The ColoSure Test
Author Information
Author(s): Ned Renée M. Melillo, Stephanie Marrone, Michael
Primary Institution: Office of Public Health Genomics, Centers for Disease Control and Prevention
Hypothesis
What is the analytic, clinical validity, and utility of the ColoSure test for colorectal cancer screening?
Conclusion
The clinical utility of the ColoSure test for colorectal cancer screening has not been established.
Supporting Evidence
- Colorectal cancer is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.
- ColoSure is the only commercially available fecal DNA test for colorectal cancer screening in the U.S.
- Research suggests that CRC screening may be responsible for approximately half of the declines in incidence and mortality since 1985.
Takeaway
ColoSure is a test that checks for signs of colorectal cancer in stool samples, but we still need more research to know how well it works.
Methodology
Literature review of published studies on the ColoSure test's validity and utility.
Potential Biases
Case-control studies may overestimate screening accuracy due to design-related bias.
Limitations
The clinical validity of ColoSure for pre-cancerous lesions is unclear, and the test has not been recommended by independent groups.
Participant Demographics
Studies primarily involved patients known to have colorectal cancer confirmed by colonoscopy.
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website