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The US Food and Drug Administration has approved Guardant Health’s Shield blood test for colorectal cancer (CRC) screening in adults aged 45 and older at average risk for the disease. The approval, announced on July 29, 2024, is based on results from the ECLIPSE study, which enrolled more than 20,000 average-risk patients. The Shield test is the first blood test to be approved by the FDA as a primary screening option for CRC and the first to meet the requirements for Medicare coverage.
"The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people. The FDA's approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap," Dr. Daniel Chung, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a press release.
The Shield test works by detecting alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals 45 years of age and older at average risk for the disease. A positive result raises concern for the presence of colorectal cancer or advanced adenoma and requires further colonoscopy evaluation.
Research published in March showed Shield was 83% effective in finding colorectal cancers. It works by detecting the DNA that cancerous tumors release into the bloodstream. It’s most effective in finding later-stage cancers, when tumors release more of that DNA. The study found that Shield only detected 13% of earlier-stage polyps.