First Stool DNA Colorectal Cancer Screening Test OK'd by FDA
The FDA has appproved Cologuard, the first non-invasive DNA screening test for colorectal cancer.
Exact Sciences has announced the Food and Drug Administration (FDA) approval of Cologuard, the first non-invasive DNA screening test for colorectal cancer.
Cologuard is used to detect the presence of hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas while stool moves through the large intestine and rectum.
If a positive test result occurs, the patient is advised to undergo a diagnostic colonoscopy. It is the first noninvasive diagnostic test for colorectal cancer that analyzes both blood biomarkers and stool DNA.
The approval of Cologuard is based on the DeeP–C clinical trial of 10,023 patients in which the performance of Cologuard was compared to the fecal immunochemical test (FIT), a common non-invasive screening test used to detect blood in the stool. Cologuard was able to detect 92% of colorectal cancers and 42% of advanced adenomas vs. 74% of colorectal cancers and 24% of advanced adenomas with FIT.
However, FIT had greater accuracy in identifying patients negative for colorectal cancer and advanced adenomas; Cologuard correctly gave a negative screening result for 87% of patients and FIT provided accurate negative screening results for 95%.
Cologuard will be available through healthcare providers and shipped directly to the patient's home. The patient collects a stool sample using the collection kit and mails the kit to Exact Sciences for testing. Results are available in as little as two weeks and collection does not require medication or dietary restrictions, or bowel preparation prior to taking the test.
For more information visit ExactSciences.com.