Guardant Health is dedicated to supporting patients with cancer across the continuum of care1
*The U.S. Food and Drug Administration (FDA) grants oversight of Lab Developed Tests (LDTs) to the Centers for Medicare and Medicaid Services (CMS). LDTs are regulated by CMS under the Clinical Laboratory Improvement Amendment (CLIA) which subjects LDTs to strict personnel, quality control, and proficiency testing standards.
Guardant Health is a leading precision oncology company that has been established for a decade with a mission to conquer cancer with data.
At Guardant Health we have now advanced our technology to include screening, for early Colorectal cancer (CRC) detection by applying a multi-modal approach to detect CRC signals in the bloodstream, including DNA that is shed by tumors.2,3,4
Colorectal cancer is the 2nd leading cause of cancer deaths among men and women6,14
Screening is the key to reducing Colorectal cancer (CRC) mortality. 60% of all CRC deaths can be prevented with regular screening12,13 – yet, 1 in 3 eligible patients remains unscreened.11
Early detection saves lives2
Screening matters for all patients
90%
of people diagnosed with CRC in early stages survive6,11
14%
of people diagnosed with CRC in late stages survive6,11
CRC screening compliance rates remain stagnant and low with current stool tests and colonoscopy20
Many factors can prevent patient follow-through for more conventional methods18,21-23
| Stool tests | Colonoscopy | |
|---|---|---|
| Barriers |
Stool tests
14-67%15-17
Compliance rate
|
Colonoscopy
38-50%16,18
Compliance rate
|
| Compliance rates |
14-67%15-17 | 38-50%16,18 |
Shield™ is a blood test that is easy to complete14-16
High compliance rate in real world clinical settings
90%1,19
High compliance rate in real world clinical settings
90%1,19
Colorectal cancer (CRC) survivor shares his story
John Gormly, who went unscreened for 20 years for colon cancer, shares his personal story of how Shield, a simple blood-based screening test, helped identify cancer during a routine wellness visit.
John’s PCP and GI worked together, to bring a simple screening solution to catch his cancer at stage 2 and get him the right treatments to save his life.
Colon cancer screening easier than ever with Shield
An accurate blood test that breaks through screening barriers and can be completed at any patient visit.2
83%
of eligible patients preferred blood-based screening25
With Shield there is:
- No special preparation
- No dietary changes
- No sedation
- No extra time away from family or work
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 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. Data on file. Guardant Health, Inc.
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. Dean J, He Y, Raymond V, et al. Plasma based cell-free circulating tumor DNA (ctDNA) assessment for non-invasive detection of colorectal cancer (CRC). Gastroenterology. 2020;158(6 suppl 1):S-369. doi:10.1016/S0016-5085(20)31616-4
5. Evaluation of the ctDNA LUNAR test in an average patient screening episode (ECLIPSE). ClinicalTrials.gov identifier: NCT04136002. https://clinicaltrials.gov/ct2/show/NCT04136002?term=NCT04136002&draw=2&rank=1
6. American Society of Clinical Oncology. Colorectal cancer: statistics. https://www.cancer.net/cancer-types/colorectal-cancer/ statistics
7. Guardant Health initiates ORACLE study to evaluate performance of Guardant Reveal™ Blood Test to predict recurrence across early-stage cancers. https://investors.guardanthealth.com/pressreleases/press-releases/2021/Guardant-Health-Initiates-ORACLE-Study-to-Evaluate-Performance-of-Guardant-Reveal-Blood-Test-to-Predict-Recurrence-Across-Early-Stage-Cancers/default.aspx
8. Guardant Health expands Guardant360® portfolio with new tests for treatment response monitoring and complete genomic profiling. https://investors.guardanthealth.com/press-releases/press-releases/2021/Guardant-Health-Expands-Guardant360-Portfolio-With-New-Tests-for-Treatment-Response-Monitoring-and-Complete-Genomic-Profiling/default.aspx
9. Guardant Health receives expanded Medicare coverage for Guardant360 across the vast majority of solid tumor cancers. https://investors.guardanthealth.com/press-releases/press-releases/2019/Guardant-Health-Receives-Expanded-Medicare-Coverage-for-Guardant360-Across-the-Vast-Majority-of-Solid-Tumor-Cancers/default.aspx 10. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. https://www.fda.gov/news-events/ press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test.
11. Colorectal cancer facts & figures 2017-2019. American Cancer Society. Accessed April 20, 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
12. Fight Colorectal Cancer: Stats and Facts. Accessed August 2020. https://fightcolorectalcancer.org/colorectal-cancer/facts-stats
13. CDC Press Release. Colorectal cancer screening rates remain low. Accessed October 2021. https://www.cdc.gov/media/releases/2013/p1105-colorectal-cancer-screening.html
14. 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. doi:10.1053/j.gastro.2018.09.040
15. 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.
16. 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
17. Exact Sciences. Third quarter 2019 webcast and conference call. Updated October 29, 2019. Accessed December 17, 2021. https:/investor.exactsciences.com/investor-relations/events-and-presentations/event-details/2019/Third-Quarter-2019-Webcast-Conference-Call/default.aspx
18. 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
19. Guardant Health. Q3 2022 Earnings Call. Accessed November 30, 2022. https://s26.q4cdn.com/594050615/files/doc_financials/2022/q3/Q3-2022-Earnings-Presentation-Final.pdf
20. Centers for Disease Control and Prevention. Cost-effectiveness of colorectal cancer interventions. Updated August 18, 2021. Accessed December 7, 2021. https://www.cdc.gov/chronicdisease/programs-impact/pop/colorectal-cancer.htm
21. 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
22. Parks P. Innovation in colorectal cancer screening - there has to be a better way. Am J Manag Care. Published October 9, 2017. Accessed September 17, 2021. https://www.ajmc.com/view/innovation-in-colorectalcancer-screening-there-has-to-be-a-better-way
23. American Society of Clinical Oncology. Colonoscopy. Cancer.net website. Updated December 2019. Accessed December 7, 2021. https://www.cancer.net/ navigating-cancer-care/diagnosing-cancer/tests-and-procedures/colonoscopy
24. ACS Colorectal Cancer Facts 2020-2022
25. 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
