FDA APPROVED FOR COLON CANCER SCREENING

Shield™ information
for clinicians

Your guide to blood-based colorectal cancer screening

The following educational resources are intended to help you become familiar with the clinical evidence supporting the efficacy and safety of Shield, a blood-based screening test for colorectal cancer

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The ECLIPSE study, published in the New England Journal of Medicine

83%

overall CRC sensitivity

90%

specificity

13%

sensitivity for advanced adenomas

23%

adenomas with High Grade Dysplasia

One of the largest studies of its kind, ECLIPSE is a 20,000+ patient registrational study conducted across 200+ clinical trial sites to evaluate the performance of the Shield test compared to a screening colonoscopy. The results were published in The New England Journal of Medicine, demonstrating the effectiveness of Shield in average-risk adults aged 45 to 84

Access the publication

Additional resources

The following educational resources are intended to help you learn more about colorectal cancer screening

GUT:
Patient adherence

PLOS ONE: Patient & provider perception

Journal of Medical Economics: CAN-SCREEN

Opinion editorial:
A new era

ACG poster:
Adherence data

ACG presentation: 1 year follow-up
ACS-NCCRT
resources
PCP partner
resources
Advocacy
support

Webinar: Colorectal Cancer Screening: Background and Moving Forward with Andrew Albert, MD MPH

FDA: Advisory committee for Shield

View the slides presented to the FDA Advisory Committee, resulting in the strong recommendation for the approval of Shield, our blood test for colorectal cancer screening as a primary non-invasive screening option

Download deck

Frequently asked questions

Patients with a positive result may have colorectal cancer or advanced adenomas should be followed by colonoscopy. The Shield blood test can be considered in a manner similar to guideline-recommended non-invasive CRC screening modalities and is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy for high-risk individuals. This is no different than what healthcare clinicians are currently doing with stool-based tests2

The Shield test demonstrates an overall sensitivity of 81.5% for detecting curable stage I through III colorectal cancers. Specifically, the sensitivity for stage I is 54.5% (or 64.7% for fully AJCC staged cancers), while Shield achieves 100% sensitivity for stages II-IV. These numbers are in range with other guideline-recommended noninvasive CRC screening options4,5,6

The Shield test has been assessed by ECLIPSE, which validated its performance as a highly sensitive blood test for CRC screening, demonstrating 83% sensitivity for CRC at 90% specificity, and 13% sensitivity for detecting advanced precancerous polyps4

In cases of a positive Shield test result with a negative colonoscopy, further CRC screening recommendations should be guided by the colonoscopy findings and should continue participating in CRC screening progams2,3

Shield is contraindicated for use in patients who have a personal history of adenomas2,3

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Offer your patients Shield: a more pleasant way to screen

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Important Product Information

Intended Use

The Shield™ test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit.
Shield is indicated for colorectal cancer screening in individuals at average risk for the disease, age 45 years or older. Patients with a positive result should be followed by colonoscopy. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. This test is performed at Guardant Health, Inc.

Precaution: Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions. One out of 10 patients with a negative Shield result may have a precancer that would have been detected by a screening colonoscopy. Shield demonstrated high detection of Stage II, III, and IV colorectal cancer.

Limitations and Other Important Information: The Shield test is not indicated for patients that have personal history of colorectal cancer, adenomas, or other related cancers; or those who had a positive result on another colorectal cancer screening method within the last six months, have been diagnosed with a condition associated with high risk for colorectal cancer such as Inflammatory Bowel Disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease; or who have a family history of colorectal cancer, or certain hereditary syndromes. Providers should discuss the most appropriate screening test to use with patients depending on their medical history and individual circumstances. Shield may produce a false negative or false positive result. A false negative result may occur when the Shield test does not detect a colorectal tumor signal while a colonoscopy identifies a colorectal cancer. A negative result does not guarantee the absence of colorectal cancer or advanced adenoma, and patients should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals. A false positive result may occur when the Shield test generates a positive result while a colonoscopy will not find colorectal cancer or advanced adenoma.

Please read our Provider Brochure for complete product information about the Shield test including full safety information.

  1. References:
  2. Coronado GD, Jenkins CL, Shuster E, et al. Blood-based colorectal cancer screening in an integrated health system: a randomized trial of patient adherence. Gut.2024;73(4):622-628. doi:10.1136/gut jnl-2023-330980.
  3. Guardant Health. Shield Colorectal Cancer Screening Test Provider Brochure. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009#:~:text=Labeling-,Labeling,-Labeling%20Part%202. Accessed Nov 5, 2024.
  4. US Preventive Services Task Force. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325(19):1965–1977. doi:10.1001/jama.2021.6238
  5. Chung DC, Grady WM, et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. NEJM. 2024;390(11):973-983, DOI: 10.1056/NEJMoa2304714
  6. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget Stool DNA Testing for Colorectal-Cancer Screening. NEJM. 2014;370(14):1287-1297. doi:10.1056/NEJMoa1311194
  7. Imperiale TF, Porter K, Zella J, et al. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. NEJM. 2024;390(11):984-993. doi:10.1056/NEJMoa2310336