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Intended Use and Important Risk Information:

The Combined Detection Kit for Human Gene Methylation and Fecal Occult Blood is a non-invasive in vitro diagnostic (IVD) assay for qualitative detection of certain genes’ methylation and fecal hemoglobin from human stool specimens. The kit is intended to be used for screening colorectal cancer in the general population. A positive test result indicates that the subject may have colorectal cancer and/or advanced adenoma, and further colonoscopy is required; on the contrary, a negative test result indicates that the subject has a low possibility of colorectal cancer and/or advanced adenoma, however, the risk of disease cannot be completely ruled out. The product is applicable to all people between the ages of 40 to 75 who need colorectal cancer screening.

This product cannot replace colonoscopy, and the test results of this kit should not be used as the only basis for clinical diagnosis. Clinicians should comprehensively judge the results based on the patient's condition and other laboratory indicators. CE marked.