From the Guidelines
Cologuard Plus is recommended for average-risk individuals aged 45 and older who need colorectal cancer screening, as it offers improved sensitivity for detecting both cancer and advanced precancerous lesions compared to the original Cologuard, as supported by recent guidelines 1. The test works by analyzing DNA biomarkers and hemoglobin in stool samples that patients collect at home using a provided kit, which is then mailed to a laboratory for analysis. For optimal results, follow all collection instructions carefully and submit your sample promptly.
Key Considerations
- Cologuard Plus is not intended to replace colonoscopy for high-risk patients or those with symptoms.
- The improved accuracy comes from advanced DNA methylation markers and enhanced analytical techniques that better identify cellular changes associated with cancer development.
- While more sensitive than the original version, it's essential to understand that no screening test is perfect, and positive results should be followed up with a diagnostic colonoscopy.
Screening Options
- Screening options for individuals at average risk for CRC should include colonoscopy, FIT, flexible sigmoidoscopy plus FIT, multitarget stool DNA-FIT, and computed tomography (CT) colonography, based on availability and individual preference, as recommended by recent guidelines 1.
- Colonoscopy has a high sensitivity for cancer and precancerous lesions and enables screening and treatment simultaneously.
Recent Guidelines
- The American Cancer Society recommends that adults aged 45 years and older with an average risk of CRC undergo regular screening with either a high-sensitivity stool-based test or a structural (visual) exam, depending on patient preference and test availability 1.
- The American College of Physicians suggests selecting the colorectal cancer screening test with the patient on the basis of a discussion of benefits, harms, costs, availability, frequency, and patient preferences 1.
From the Research
Cologuard Plus Overview
- Cologuard Plus is not explicitly mentioned in the provided studies, but the studies discuss various screening strategies for colorectal cancer (CRC) including multi-target stool DNA (mt-sDNA) test, which is related to Cologuard.
- The US Preventive Services Task Force recommends screening with one of several screening strategies, including mt-sDNA test, for average-risk individuals to reduce CRC incidence and mortality in the United States 2.
- Emerging and novel CRC screening modalities, such as blood-based screening or "liquid biopsy," colon capsule endoscopy, urinary metabolomics, and stool-based microbiome testing, are not yet approved for first-line screening in average-risk individuals 2.
Screening Strategies
- Flexible sigmoidoscopy and fecal immunochemical tests are established diagnostic tests for CRC screening and are less invasive, less expensive, and easier to conduct than colonoscopy 3, 4.
- Combining flexible sigmoidoscopy and fecal immunochemical testing might strongly enhance diagnostic performance of each single test to a level close to the diagnostic performance of screening colonoscopy while avoiding many unnecessary colonoscopies 3, 5.
- The diagnostic performance of flexible sigmoidoscopy combined with fecal immunochemical test in colorectal cancer screening has been assessed in meta-analyses and modeling studies, showing improved sensitivity and specificity for detecting CRC and advanced adenoma 5.
Recommendations
- Patients and providers should engage in informed decision-making about the benefits and limitations of recommended screening options to determine the most appropriate screening test 2.
- Health systems should have a programmatic approach to CRC screening, which may include evidence-based strategies such as patient education, provider education, mailed screening outreach, and/or patient navigation, to maximize screening participation 2.
- The American College of Gastroenterology recommends CRC screening in average-risk individuals and those with a family history of CRC, and provides recommendations on the role of aspirin for chemoprevention, quality indicators for colonoscopy, and approaches to organized CRC screening 6.