Innovations in Non Invasive Colorectal Cancer (CRC) Screening

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Innovations in Non Invasive Colorectal Cancer (CRC) Screening

Program Information

Program Information

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What strategies can we use to help close the gap in colorectal cancer screening?

  • Overview

    The purpose of screening is not only to detect colorectal cancers, but to detect them in earlier stages to help improve survival rates. Despite the importance of screening, many patients who should be screened for colorectal cancer are not. To find out more about the barriers that can keep patients from being screened and how a noninvasive screening option like Cologuard® may help overcome those obstacles, Dr. Charles Turck speaks with Dr. Durado Brooks, Deputy Chief Medical Officer at Exact Sciences.

    US.CG.4970-1-October 2021

  • Important Risk Information

    Indications and Important Risk Information

    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. Cologuard is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

    Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease; or have a family history of colorectal cancer, or certain hereditary syndromes.

    Positive Cologuard results should be referred to diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient.

    False positives and false negatives do occur. In a clinical study, 13% of patients without colorectal cancer or advanced adenomas received a positive result (false positive) and 8% of patients with cancer received a negative result (false negative). The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

    Cologuard performance when used for repeat testing has not been evaluated or established. Rx only.

Schedule27 Jun 2022
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