Offer your patients Shield—the patient preferred CRC screening test9,10
People who are not up to date with colorectal cancer (CRC) screening are at increased risk of CRC1
Did you know?
CRC is highly preventable, yet
75% of people who died
from it were not up to date on screening1,2
CRC is still the 2nd-leading cause of cancer-related deaths in the US3
Compliance rates remain stagnant and low2
Current CRC screening methods |
Compliance rates |
|---|---|
Stool tests4,5 |
14-67% |
Colonoscopies5,6 |
38-50% |
Due to compliance barriers with these existing modalities, many patients continue to go unscreened6
Shield™ is an easy-to-complete blood test that can help overcome barriers and increase compliance7
ECLIPSE validates Shield as a high-sensitivity blood test for CRC screening
Sensitivity7*
83%
CRC Overall
Specificity7*
90%
High compliance rate in real-world clinical settings8†
90%
90%
*The ECLIPSE study (NCT04136002) is comparing the sensitivity and specificity of Shield with findings from subsequent colonoscopy in over 10,000 average-risk patients.7 Patients had no prior diagnosis of CRC, inflammatory bowel disease, or family history of genetic risk for CRC (eg, Lynch syndrome).11 Specificity detected for advanced neoplasia in ECLIPSE includes CRC and advanced adenomas; overall sensitivity shown is for CRC.10
†Compliance rate for the first 20,000 patients who were prescribed Shield.8
Shield™ is a qualitative laboratory developed test intended to detect colorectal cancer by identifying genomic and epigenomic alterations in cell-free DNA in plasma from blood collected in Guardant blood collection tubes.
- The assay is intended to be complementary to and not a replacement for current recommended colorectal cancer screening methods
- Patients with an “abnormal signal detected” Shield result should be referred for colonoscopic evaluation
- A “normal signal detected” Shield result does not preclude the presence of colorectal cancer, and patients should continue participating in guideline-recommended screening programs
- Shield was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical testing. This test has not been cleared or approved by the US FDA
References
1. Doubeni CA, Fedewa SA, Levin TR, et al. Modifiable failures in the colorectal cancer screening process and their association with risk of death. Gastroenterology. 2019;156(1):63-74.e6 doi:10.1053/j.gastro.2018.09.040
2. American Cancer Society. Colorectal Cancer Facts & Figures 2020-2022. Atlanta: American Cancer Society; 2020.
3. American Society of Clinical Oncology. Colorectal cancer: statistics. Cancer.net website. February 2023. Accessed November 8, 2023. https://www.cancer.net/cancer-types/colorectal-cancer/statistics
4. Gellad ZF, Stechuchak KM, Fisher DA, et al. Longitudinal adherence to fecal occult blood testing impacts colorectal cancer screening quality. Am J Gastroenterol. 2011;106(6):1125-1134. doi:10.1038/ajg.2011.11
5. Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582. doi:10.1001/archinternmed.2012.332
6. Denberg TD, Melhado TV, Coombes JM, et al. Predictors of nonadherence to screening colonoscopy. J Gen Intern Med. 2005;20(11):989-995. doi:10.1111/j.1525-1497.2005.00164.x
7. Chung DC, Gray DM II, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening. N Engl J Med. 2024;390(11):973-983. doi:10.1056/NEJMoa2304714
8. Data on file. Guardant Health, Inc.
9. Liles EG, Coronado GD, Perrin N, et al. Uptake of a colorectal cancer screening blood test is higher than of a fecal test offered in clinic: a randomized trial. Cancer Treat Res Commun. 2017;10:27-31. doi:10.1016/j.ctarc.2016.12.004
10. Schneider JL, Johnson CA, Jenkins C, Mummadi R, Coronado GD (2023) “I was screaming hallelujah”: Patient and provider perceptions of blood-based testing for colorectal cancer screening. PLoS One. 2023;18(12):e0295685
11. Evaluation of the ctDNA LUNAR test in an average patient screening episode (ECLIPSE). ClinicalTrials.gov identifier: NCT04136002. Updated September 22, 2021. Accessed November 24, 2021. https://clinicaltrials.gov/ct2/show/NCT04136002?term=NCT04136002&draw=2&rank=1
