Blood test that detects colon cancer close to receiving FDA approval
Doctors and scientists say the Guardant Shield blood test could help identify more cases of colorectal cancer because people are more likely to take a blood test than undergo a colonoscopy.
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A blood test that detects colon cancer is one step closer to being approved by the Food and Drug Administration.
The Guardant Shield blood test has been available for two years and costs $900 out of pocket. Earlier this week, seven out of nine doctors and scientists on a FDA advisory panel voted yes to approve the test for colorectal cancer screening.
They say the test could help identify more cases of colorectal cancer because people are more likely to take a blood test than undergo a colonoscopy. An estimated 60% of people skip a colonoscopy. Test results take close to two weeks.
Data published New England Journal of Medicine show that the test was 83% effective in detecting colon cancer. However, expects say the test is not as accurate as a colonoscopy and would not replace it as the gold standard for colon cancer detection because the test is also not as successful in detecting pre-cancer.
Doctors say that is one of the most important reasons they recommend people get a colonoscopy.
If Shield gets full approval by the FDA, it would be first approved blood screening test for colorectal cancer that meets requirements for Medicare reimbursement. People ages 45 or older who are at average risk of the disease would be encouraged to use Shield. It would not be recommended for people who are considered high-risk to personal or family history of the disease.
