Our Shield™ blood test gains FDA approval, ushering in a new era of colorectal cancer screening.  More details

Patients who are not up to date with screening
are at increased risk of CRC mortality1

Did you know?

Over 75% of people who died from CRC
were not up to date with screening1

CRC remains the second-leading
cause of cancer-related deaths in
the United States.2

CRC screening can drastically increase survival outcomes when detected early2,3

5-YEAR SURVIVAL RATE

BASED ON STAGE OF DIAGNOSIS2,3

Early Stage
(I-II)
90%
Late Stage
(IV)
14%
Sadly, low screening compliance may contribute to over half of patients
getting diagnosed after their disease has spread.4,5

CRC screening compliance rates remain stagnant and low with current stool tests and colonoscopy6

Many factors can prevent patient follow-through for more conventional methods7-10

  Stool tests Colonoscopy
Barriers
Stool tests
  • Discomfort or disgust with handling stool
  • Inconvenience of collecting and mailing stool sample
  • Apprehension about accurately completing a test at home
14-67%11-13
Compliance rate
Colonoscopy
  • Fear of an invasive procedure and associated risk
  • Discomfort with bowel prep
  • Burden and time required for an inpatient procedure, including prep and recovery time
38-50%8,12
Compliance rate
Compliance
rates		 14-67%11-13 38-50%8,12
Shield™ is a blood test that is easy to complete14-16

High compliance rate in real world clinical settings

90%17,18* Test tube with blood.
Learn about the benefits of Shield

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*Compliance rate for the first 8,000 patients that were prescribed Shield and completed it.18
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. 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 2. American Society of Clinical Oncology. Colorectal cancer: statistics. Cancer.net website. Updated January 2021. Accessed May 10, 2021. https://www.cancer.net/cancer-types/colorectal-cancer/statistics 3. American Cancer Society. Colorectal cancer facts & figures 2017-2019. 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 4. National Cancer Institute. Colon and rectum stage distribution of SEER incidence cases, 2009-2018. 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 5. Andrew AS, Parker S, Anderson JC, et al. Risk factors for diagnosis of colorectal cancer at a late stage: a population-based study. J Gen Intern Med. 2018;33(12):2100-2105. doi:10.1007/s11606-018-4648-7 6. 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 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. 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 9. 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-colorectal-cancer-screening-there-has-to-be-a-better-way 10. 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 11. 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 12. 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 13. 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 14. 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 15. 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 16. 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 17. Data on File. Guardant Health. 18. 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