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FDA approves Exact Sciences' colorectal screening test

  • The FDA clears Exact Sciences' (EXAS +2.5%) Cologuard, a stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancerous or pre-cancerous. Patients who test positive with Cologuard are advised to undergo a diagnostic colonoscopy.
  • Concurrently, the Centers for Medicare & Medicaid Services (CMS) issue proposed coverage guidelines targeting asymptomatic patients aged 50 - 85 years that are average risk of developing colorectal cancer. CMS proposes to cover the cost of the test once every three years.
  • EXAS shares are up 4% AH on average volume.
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