Shield’s Inclusion in ACS Guidelines Marks a Significant Milestone for Colorectal Cancer Screening
The American Cancer Society (ACS) has taken a major step forward by recommending Guardant Health’s FDA-approved Shield blood test for colorectal cancer (CRC) screening. This update introduces Shield as a screening choice for more than 50 million eligible Americans who remain unscreened—despite CRC being the second leading cancer killer in the U.S. and the top cause for adults under 50.
Shield Is the First and Only FDA-Approved CRC Blood Test Recognized by Both ACS and NCCN
What sets Shield apart is its unique position as the only FDA-approved blood-based colorectal screening test included in both the updated ACS guidelines and those of the National Comprehensive Cancer Network (NCCN). Shield is now recommended for adults aged 45 and older who either decline or have not completed traditional stool-based or visual exams. With a simple blood draw during a routine doctor’s visit, Shield aims to break down barriers to screening, particularly for patients reluctant or unable to complete colonoscopies or stool tests.
Shield Demonstrates High Patient Adherence and Clinical Sensitivity
| Metric | Shield Blood Test | Traditional Screening |
|---|---|---|
| Screening Adherence (Real-World) | 90%+ | Lower1 |
| Tested Patients (Approximate) | 200,000 | - |
| Sensitivity (Stage II+ Cancers) | 100% | Varies |
According to data from real-world use, more than 90% of patients who try Shield complete the test, compared with lower completion rates for colonoscopies or stool-based tests. In the pivotal ECLIPSE study, Shield demonstrated 100% sensitivity in detecting stage II and higher colorectal cancers.
Expanded CRC Screening Options May Drive Participation Among Unscreened Populations
The persistent screening gap is striking: Three out of four CRC deaths occur in people not current with screening. The updated ACS guidelines address barriers, especially for those aged 45–55, racial and ethnic minorities, and individuals with lower socioeconomic status. Shield's blood-based, non-invasive approach provides a practical method to connect with such groups, potentially improving both access and outcomes.
Industry Reactions Emphasize Choice and Education
Healthcare leaders agree that providing multiple approved screening options encourages informed decision-making and increases participation rates. As Chris Evans, President of the Colon Cancer Coalition, said, “The introduction of a blood-based choice for colorectal cancer screening will increase rates and ultimately save lives.”
Key Takeaway: New Guidelines Recognize Multiple Approved Methods—Shield Emerges as a Promising Choice for Difficult-to-Reach Patients
For the millions left unscreened by traditional approaches, Shield’s inclusion in national guidelines represents a promising pathway to improved cancer detection and public health outcomes. As screening options multiply, the likelihood of reaching the ACS’s 80% screening rate target in every community grows—bringing the U.S. closer to narrowing one of cancer care’s most critical gaps.
References:
1. Cullison J. A blood-based test for colorectal cancer screening. HCA Healthc J Med. 2025.
2. Chung, D. C., et al. New England Journal of Medicine, 2024.
3. American Cancer Society National Colorectal Cancer Roundtable.
4. ACS Statistics: https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
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