FDA approves blood test for colon cancer

The FDA has approved Guardant Health’s Shield blood test for colon cancer screening.

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The Shield blood test has been approved as a primary screening method for adults over 45 with an average risk for colon cancer, according to a July 29 news release from Guardant.

With FDA approval, the Shield blood test becomes the first colon cancer screening method that meets Medicare coverage requirements. 

The blood test can be administered during a routine blood draw, potentially leading to a higher rate of colon cancer screening compared to more invasive screening method options. 

“This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era,” Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital in Boston and professor of medicine at Harvard Medical School, said in the release. “With increased screening rates and early cancer detection, many more lives can be saved.”

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