Frequently Asked Questions (FAQs)
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What is a blood-based screening test for colorectal cancer and how does it work?
Why is Guardant Health developing a blood-based approach for CRC detection?
How can I order the Shield™ test?
How long does it take for Shield test results to be available?
As an employer, I am interested in offering a blood-based colorectal cancer screening program to my employees. Who do I contact?
What is the ECLIPSE trial and where can I find more information?
How can I stay updated on the latest developments with Guardant Health’s blood-based CRC screening test or the ECLIPSE trial?
What preparations are necessary for a blood-based screening test?
What are the current USPSTF recommendations for CRC screening?
What financial assistance does Guardant Health provide?
Who should I contact if I have additional questions?
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Shield™ is a qualitative laboratory developed test intended to detect colorectal neoplasia by identifying genomic and epigenomic alterations in cell-free DNA and proteomic changes 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 test result should be referred for colonoscopic evaluation
- A "normal signal detected" Shield test 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
References1. Lee J, Kim HC, Kim ST, et al. Multimodal circulating tumor DNA (ctDNA) colorectal neoplasia detection assay for asymptomatic and early-stage colorectal cancer (CRC). J Clin Oncol. 2021;39(suppl 15):3536. 2. Kim ST, Raymond VM, Park JO, et al. Combined genomic and epigenomic assessment of cell-free circulating tumor DNA (ctDNA) improves assay sensitivity in early-stage colorectal cancer (CRC). Cancer Res. 2019;79(suppl 13):916. doi:10.1158/1538-7445.AM2019-916 3. Westesson O, Axelrod H, Dean J, et al. Integrated genomic and epigenomic cell-free DNA (cfDNA) analysis for the detection of early-stage colorectal cancer. Cancer Res. 2020;80(suppl 16):2316. doi:10.1158/1538-7445.AM2020-2316 4. Adler A, Geiger S, Keil A, et al. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014;14:183. doi:10.1186/1471-230X-14-183 5. 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 6. American Society of Clinical Oncology. Colorectal cancer: statistics. Cancer.net website. Updated January 2021. Accessed May 10, 2021. https: -74 . doi: 10 .1053 /j .gastro .2018 .09 .040 // 7. American Cancer Society. Colorectal cancer facts & figures 2017-2019. Accessed April 20, 2021. https: www .cancer .net /cancer -types /colorectal -cancer /statistics // 8. National Cancer Institute. Colon and rectum stage distribution of SEER incidence cases, 2009-2018. Accessed November 10, 2021. https: www .cancer .org /content /dam /cancer -org /research /cancer -facts -and -statistics /colorectal -cancer -facts -and -figures /colorectal -cancer -facts -and -figures -2017 -2019 .pdf // 9. Guardant Health. Second quarter 2021 earnings call. Published August 5, 2021. Accessed November 10, 2021. https: seer .cancer .gov /explorer /application .html ?site = 20 & data _type = 1 & graph _type = 4 & compareBy = sex & chk _sex _3 = 3 & chk _sex _2 = 2 & race = 1 & age _range = 1 & advopt _precision = 1 // 10. 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: s26 .q4cdn .com /594050615 /files /doc _financials /2021 /q2 /final -080521 -guardant -health -q2 -2021 -earnings -call .pdf // 11. Rich T, Raymond V, Lang K. Where are we today? Efforts to understand strategies and barriers to physician issuance of a recommendation for colorectal cancer screening: a systematic review. Gastroenterology. 2020;158(6 suppl 1):S-918. doi:10.1016/S0016-5085(20)32981-4 12. Davidson KW, Barry MJ, Mangione CM, et al; 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 clinicaltrials .gov /ct2 /show /NCT04136002 ?term = NCT04136002 & draw = 2 & rank = 1