In the US and many EU27 countries, both fecal occult blood test (FOBT) and colonoscopy
are recommended and reimbursed for CRC screening. FOBT is low cost and non-invasive but
lacks sensitivity & specificity. Colonoscopy has high sensitivity and specificity but is invasive,
expensive, and patient compliance with screening guidelines is poor. Fecal DNA-based
testing will have a sensitivity & specificity comparable to colonoscopy but will be more
acceptable to patients. It can be priced to offer 3rd party payers a cost advantage over
colonoscopy while providing a very attractive margin to clinical labs. The American Cancer
Society and the U.S. Multi-Society Task Force on Colorectal Cancer endorse fecal DNA-
based testing as an option for CRC screening.


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