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Epic Test Code LAB13001 Cologuard

Important Note

This test is intended for the use with patents ≥ 45 years of age, at average risk who are typical candidates for CRC screening.

Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy.
 

Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy.

 

It is highly recommend Cologuard patients call their insurance carrier directly to confirm what the insurance carrier will pay, what the insurance carrier expects the patient to pay, and if the patient or prescriber needs to file any paperwork (like a prior authorization) before the patient uses the test.

 

Insurance information for patients (please give to patient when ordering testing)

Specimen Required

Spontaneously passed stool specimen collected and transported using a Cologuard collection kit, following the enclosed patient instructions

Minimum Volume

1.0 - 299.0 grams of stool

Specimen Stability

72 hours from collection at Room Temperature

Report Available

10 business days from receipt of specimen at Exact Sciences Laboratories

Maximum Laboratory Time

7 - 10 days once received at Exact Sciences

Reference Values

Negative

Days of Analysis

Monday - Saturday

Limitations

Cologuard was not clinically evaluated for the following types of patients:

  • Patients with a history of colorectal cancer, adenomas, or other related cancers.
  • Patients who have had a positive result from another colorectal cancer screening method within the last 6 months.
  • Patients who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as Hereditary non-polyposis colorectal cancer syndrome (HNPCCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, Familial Hyperplastic Polyposis.
  • Patients who have been diagnosed with a condition that is associated with high risk for colorectal cancer. These include but are not limited to:
    • Inflammatory Bowel Disease (IBD)Chronic ulcerative colitis (CUC)
    • Crohn’s disease
    • Familial adenomatous polyposis (FAP)
    • Family history of colorectal cancer

Methodology

Quantitative Allele-specific Real-time Target and Signal Amplification (QuARTS) and Enzyme-Linked Immunosorbent Assay (ELISA) for fecal hemoglobin

Synonyms

Stool-based DNA test with hemoglobin immunoassay component and algorithmic analysis

Colorectal Cancer Screen (CRC)

CPT Code

81528
 

Last Updated

21-Jan-22