FDA approves blood test to detect early signs of colorectal cancer
press release from Guardant Health on Monday . “The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap.
This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era.
With increased screening rates and early cancer detection, many more lives can be saved.”The FDA approval comes following a clinical trial that included 20,000 participants across 200 sites across the US. “Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia [tumors],” said the press release. “This performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.”Following news of the FDA approval, Guardant Health announced its Shield blood test is now commercially available, as of today. “The commercial launch of the Shield test and Medicare coverage make it possible for millions of eligible individuals to access a convenient, more pleasant way to stay up to date with colorectal cancer screening and detect the disease early, when it is more easily treated,” said AmirAli Talasaz, Guardant Health co-CEO. “From day one, Shield will be covered for more than 45 million Medicare beneficiaries, including many who are non-compliant with colonoscopy.”Some men in the study were encouraged to examine each other.
