There are many colorectal cancer screening options used to detect early cancer risk, such as the SHIELD blood test, and HEDIS-recognized screening methods, including visual and structural exams and stool-based tests.
While SHIELD may increase screening access for some patients, it detects substantially fewer precancerous lesions than established screening options and should not replace HEDIS-recognized methods in provider workflows.
Why HEDIS-recognized methods are the better choice
The SHIELD blood test is FDA-approved and covered by Medicare for colorectal cancer screening, but providers should not rely on it to close HEDIS care gaps. HEDIS measures align with U.S. Preventive Services Task Force guidelines, which currently exclude blood-based screening due to insufficient evidence on long-term outcomes and mortality reduction.
HEDIS-recognized methods for quality performance and gap closure include the following screening options:
- Colonoscopy
- CT colonography
- Fecal immunochemical test (FIT)
- FIT-DNA
- Flexible sigmoidoscopy
The performance data reinforces this recommendation. In an ECLIPSE study, SHIELD demonstrated 83% overall colorectal cancer sensitivity, 87% sensitivity for Stage I–III colorectal cancer, and 90% specificity. However, its sensitivity for advanced adenomas was approximately 13%, far below FIT-DNA's 42% and colonoscopy’s 95%.
Because advanced adenomas are precancerous lesions, methods that detect them more reliably offer a stronger opportunity to prevent colorectal cancer before it develops.
Comparison of colorectal cancer screening test performance
Guardant Health. ECLIPSE Clinical Study Results for SHIELD Blood Test. 2023.
Key takeaway: prioritize HEDIS-recognized screening
Although blood-based screening may help some patients complete a screening test, SHIELD should not replace HEDIS-recognized colorectal cancer screening methods. To close QPP care gaps and support better prevention, Select Health encourages providers to continue using recognized screening methods whenever clinically appropriate.
Additional Information
REFERENCES
- Guardant Health. ECLIPSE Clinical Study Results for SHIELD Blood Test. 2023.
- Imperiale TF, et al. Multitarget Stool DNA Testing for Colorectal-Cancer Screening. N Engl J Med. 2014.
- National Committee for Quality Assurance (NCQA). HEDIS® Colorectal Cancer Screening Measure Specifications.
- U.S. Preventive Services Task Force (USPSTF). Colorectal Cancer Screening Recommendation Statement. JAMA. 2021.