DNA-Based Colon Cancer Test Gets FDA Nod
the MPR take:
An FDA advisory panel has unanimously recommended approval of the Cologuard screening test, manufactured by Exact Sciences. Although colonoscopy is the standard for for colon cancer and polyps detection, a large clinical trial of the DNA test detected 92.3% of colorectal cancers in average-risk patients. The test evaluates a combination of DNA and hemoglobin markers present in abnormal cells shed in the stool; if the test results are positive for cancer, the patient would need to undergo a colonoscopy.
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