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

 
• By Natasha
  
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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.

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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