Shield Colorectal Cancer Screening Test Indications
Shield is a blood-based colorectal cancer screening test, and based on current evidence-based guidelines, it should NOT be used for colorectal cancer screening because blood-based tests lack proven mortality benefit and are explicitly not recommended by major guideline organizations. 1, 2, 3
Why Blood-Based Tests Are Not Recommended
- The American College of Physicians explicitly recommends against using serum screening tests for colorectal cancer due to lack of evidence for mortality benefit. 3
- The U.S. Multi-Society Task Force specifically recommends against the Septin9 serum assay for screening due to insufficient evidence. 3, 4
- Blood-based tests are not recommended for colorectal cancer screening in asymptomatic average-risk adults because they lack the evidence base that supports mortality reduction, which is the primary outcome that matters. 3
What Should Be Used Instead
First-Tier Screening Options (Strongly Recommended)
- Colonoscopy every 10 years is the preferred screening modality with strong evidence for mortality reduction. 1, 2, 4
- Annual fecal immunochemical test (FIT) is the other cornerstone screening test with proven mortality benefit. 2, 3, 4
- These two tests should be offered first to all eligible patients, as they have the strongest evidence for reducing colorectal cancer deaths. 2, 4
Second-Tier Screening Options (Acceptable Alternatives)
- Multitarget stool DNA test (Cologuard) every 3 years is classified as a second-tier option when patients decline colonoscopy or FIT. 2, 4
- CT colonography every 5 years is another second-tier alternative. 5, 4
- Flexible sigmoidoscopy every 5-10 years (alone or combined with FIT) is also acceptable. 5, 3, 4
Age-Based Screening Recommendations
Average-Risk Adults
- Begin screening at age 45 years for all average-risk adults, though this is a qualified recommendation. 5
- Screening from age 50-75 years carries a strong recommendation with the most robust evidence for mortality benefit. 5, 2
- Continue screening through age 75 years in adults with life expectancy greater than 10 years. 5, 2, 3
- Individualize screening for ages 76-85 years based on prior screening history, overall health status, and life expectancy exceeding 10 years. 5, 2
- Discontinue screening after age 85 years as harms outweigh benefits regardless of prior screening history. 5, 2, 3
High-Risk Adults (Family History)
- Begin colonoscopy at age 40 years or 10 years before the youngest affected relative's diagnosis (whichever comes first) for individuals with a first-degree relative diagnosed with colorectal cancer before age 60, or two or more first-degree relatives diagnosed at any age. 5, 1, 4
- Repeat colonoscopy every 5 years in these high-risk individuals. 5, 1, 4
- These individuals have a 3-4 times higher lifetime risk compared to average-risk populations. 1
Critical Exclusions for Any Screening Test
- Never use screening tests in symptomatic patients with alarm symptoms including rectal bleeding, narrowed stools, unexplained weight loss, or change in bowel habits—these patients require immediate diagnostic colonoscopy regardless of any screening test results. 2, 3
- Do not screen if life expectancy is less than 10 years due to comorbidities, as screening is unlikely to provide benefit. 5, 2, 3
- Screening tests are only for average-risk individuals without family history of colorectal cancer, inflammatory bowel disease, genetic syndromes, or personal history of colorectal cancer or adenomatous polyps. 2
Common Pitfalls to Avoid
- Do not use blood-based tests like Shield or Septin9 as they are not guideline-endorsed and lack mortality benefit evidence. 3, 4
- Do not continue screening past age 75 years in patients with adequate prior negative screening history, as harms increasingly outweigh benefits. 2, 3
- All positive stool-based tests require follow-up colonoscopy—failure to complete diagnostic workup renders the screening program ineffective. 5, 2, 3
- Verify family history details carefully including exact diagnosis, age at diagnosis, and relationship of affected relatives, as this information is often incomplete or inaccurate. 1