General Disclaimer

Intended Use
  • Shield is a qualitative in vitro diagnostic test intended to detect colorectal neoplasia by identifying genomic and epigenomic alterations in cell-free DNA.
  • Shield is intended for colorectal cancer screening in individuals at average risk for the disease, age 45 years or older, and is not intended to be the sole basis for a diagnosis of colorectal cancer.

Important Safety Information
  • Shield is for prescription use only. This test should not be used if you have:
    • A personal history of colorectal cancer (CRC)
    • A family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age
    • A known hereditary / germline risk of CRC (for example, Lynch syndrome or Hereditary Non-Polyposis CRC, or Familial Adenomatous Polyposis)
    • A known diagnosis of inflammatory bowel disease
  • False positive and false negative results may occur.
  • An Abnormal Signal Detected suggests the presence of colorectal cancer or advanced adenoma. Patients with an Abnormal Signal Detected result should be referred for colonoscopy evaluation.
  • Shield has limited ability to detect advanced adenomas.
  • A normal Shield result does not rule out colorectal cancer and patients should continue participating in guideline-recommended screening programs.
  • Shield should be considered alongside other CRC screening modalities, like colonoscopy, and is not a replacement for diagnostic or surveillance colonoscopy of high-risk individuals.

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