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Guardant’s FDA Approval For Colorectal Cancer Blood Test, Paves Road To Potential Medicare Coverage

 
• By Natasha Barrow

  On 29 July, Guardant Health Inc. announced it received US FDA approval for its blood test Shield to be used as a primary screening option for colorectal cancer, bringing it one step closer to gaining Medicare coverage.

Blood test
• Source: Shutterstock

Guardant Health, Inc. said its Shield blood test is the first blood test approved by the US Food and Drug Administration (FDA) as a primary screening option for colorectal cancer and the first such test to meet requirements for Medicare coverage. The FDA decision follows a strong recommendation for approval by an advisory committee panel in May and was based on results of the ECLIPSE study, a 20,000-plus patient registrational study evaluating the performance of the test for detecting colorectal cancer in average-risk adults. Results published in the New England Journal of Medicine indicated Shield met the current guideline-recommended noninvasive screening methods, requiring overall colorectal cancer test sensitivity to range from 74% to 92%, reported the company.

Shield demonstrated 83% sensitivity for the detection of colorectal cancer, with 90% specificity for advanced neoplasia, defined as tumors of...

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