Performance Evaluation of the Micromedic CD24 Western Blot and ELISA in Vitro Diagnostic Assay
Inclusion Criteria:
- Subject is 50 years old and above
- Subject is asymptomatic and referred for regular recommended screening colonoscopy or
subject is referred due to suspicion of colon cancer, prior to beginning of any
treatment (enriched population)
- Subject signed the informed consent
Exclusion Criteria:
- Subject has been previously diagnosed with any type of cancer
- Subject has been previously diagnosed with a colorectal abnormality such as
colorectal adenoma, hyperplastic polyp or carcinoma
- Blood sample was not collected on the day of colonoscopy and prior to colonoscopy
- Subject has first degree family history of colorectal cancer
- Subject has active infection or inflammation as determined clinically at screening
- Subject is currently taking medications related to the previous exclusion criteria
- Subject has participated in, or is participating in, any investigational drug or
device study within 30 days prior the date of colonoscopy and any additional study
required test
- Pregnant or lactating woman