New ECLIPSE study validates the accuracy of Shield.  See the data


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 due for 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 compliance7,8

ECLIPSE validates Shield as a high-sensitivity blood test for CRC screening

Specificity8,†
90%
Sensitivity8,†
83%
CRC Overall
High compliance rate in real-world clinical settings9,10,*
90%
Test tube with blood.

*Compliance rate for the first 8,000 patients that were prescribed Shield and completed it.9
The ECLIPSE study (NCT04136002) is comparing the sensitivity and specificity of Shield with findings from subsequent colonoscopy in over 10,000 average-risk patients.9,12 Patients had no prior diagnosis of CRC, inflammatory bowel disease, or family history of genetic risk for CRC (eg, Lynch syndrome). Specificity detected for advanced neoplasia in ECLIPSE includes CRC and advanced adenomas; overall sensitivity shown is for CRC.12
Shield™ is a qualitative laboratory developed test intended to detect colorectal neoplasia 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 neoplasia, 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. 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 8. Chung DC, Gray DM, Greenson J, et al. Clinical validation of a cell-free DNA blood-based test for colorectal cancer screening in an average risk population. Abstract presented at: Digestive Disease Week 2023; May 6-9, 2023; Chicago, IL. #913e. 9. Guardant Health announces positive results from pivotal ECLIPSE study evaluating a blood test for the detection of colorectal cancer. December 15, 2022. Accessed November 8, 2023. https://investors.guardanthealth.com/press-releases/press-releases/2022/Guardant-Health-announces-positive-results-from-pivotal-ECLIPSE-study-evaluating-a-blood-test-for-the-detection-of-colorectal-cancer/default.aspx 10. Raymond VM, Foster G, Hong Y, et al. Implementation of blood-based colorectal cancer (CRC) screening: Real-world clinical experience. P3027. Poster presented at ACG 2023 ePoster hall; October 24, 2023. https://acg2023posters.eventscribe.net/fsPopup.asp?PosterID=597696&Query=Implementation+of+Blood-Based+Colorectal+Cancer&mode=posterInfo 11. Johnson CA, Mummadi R, Schneider J, et al. “I Was Screaming Hallelujah”: Patient and provider perceptions of blood-based testing for colorectal cancer screening. P3169. Poster presented at ACG 2023 ePoster hall; October 24, 2023. https://acg2023posters.eventscribe.net/fsPopup.asp?efp=RVdKUVpPTUUyMDQ1MQ&PosterID=597452&rnd=0.1262501&mode=posterInfo 12. National Library of Medicine, ClinicalTrials.gov. Evaluation of the ctDNA LUNAR test in an Average Patient Screening Episode (ECLIPSE). NCT04136002. Available at https://classic.clinicaltrials.gov/ct2/show/NCT04136002. Accessed November 8, 2023.