FDA APPROVED FOR COLORECTAL CANCER (CRC) SCREENING

Let's improve the
stagnant state of
CRC screening

Many patients don’t adhere to traditional modalities, which leads to a high number of preventable deaths. Offer the Shield™ blood test as an option to get more patients screened1-3

Request info

CRC is the 2nd-deadliest
cancer in the US4

~50 million
people

remain unscreened5

3 out of 4

3 out of 4

people who died of CRC were not up to date with screening6

In a study of 1750 patients who died of CRC between 2006 and 2012

Patients live longer when
CRC is detected early7

5-year relative survival rates based on stage at diagnosis7,8

Localized (I-II)

91%

Distant (IV)

16%

SEER 22 5-year relative survival data for colorectal cancer; obtained from 2014-2020

It is estimated that nearly 70% of CRC-related deaths in 2023 were in patients ≥65 years of age.

~70%

of CRC-related deaths

in 2023 were in patients ≥65 years of age9

Estimate from the American Cancer Society

CRC is highly treatable if detected early,
yet many people remain unscreened9,10

What stands in the way of your patients getting screened for CRC?

Logistical challenges. Lack of urgency. When it comes to traditional screening tests, patients also mention11,12:

Hassle

of unpleasant and extensive preparation

Aversion

to handling stool

Worry

about an invasive procedure

Offer your patients Shield: a more pleasant way to screen

Request info

The challenge to meet the nationwide goal of 80% screening adherence still persists5

That's where the Shield
blood test comes in

*Internal data on file, March 2024. Based on the first 20,000 patients offered Shield. Data from real-world clinical settings. Data based on Laboratory Developed Test (LDT) usage of Shield, which has not been cleared or approved by the FDA

See how Shield performs

“People know that it’s important to be screened, but there are barriers that prevent them from doing it”

—
Daniel Ripley, MD
Family Practice
Physician

Important Product Information

Intended Use

The Shield™ test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit.
Shield is indicated for colorectal cancer screening in individuals at average risk for the disease, age 45 years or older. Patients with a positive result should be followed by colonoscopy. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. This test is performed at Guardant Health, Inc.

Precaution: Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions. One out of 10 patients with a negative Shield result may have a precancer that would have been detected by a screening colonoscopy. Shield demonstrated high detection of Stage II, III, and IV colorectal cancer.

Limitations and Other Important Information: The Shield test is not indicated for patients that have personal history of colorectal cancer, adenomas, or other related cancers; or those who had a positive result on another colorectal cancer screening method within the last six months, have been diagnosed with a condition associated with high risk for colorectal cancer such as Inflammatory Bowel Disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease; or who have a family history of colorectal cancer, or certain hereditary syndromes. Providers should discuss the most appropriate screening test to use with patients depending on their medical history and individual circumstances. Shield may produce a false negative or false positive result. A false negative result may occur when the Shield test does not detect a colorectal tumor signal while a colonoscopy identifies a colorectal cancer. A negative result does not guarantee the absence of colorectal cancer or advanced adenoma, and patients should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals. A false positive result may occur when the Shield test generates a positive result while a colonoscopy will not find colorectal cancer or advanced adenoma.

Please read our Provider Brochure for complete product information about the Shield test including full safety information.

  1. References:
  2. Meester RGS, Doubeni CA, Lansdorp-Vogelaar I, et al. Colorectal cancer deaths attributable to nonuse of screening in the United States. Ann Epidemiol. 2015;25(3):208-213.e1. doi: 10.1016/j.annepidem.2014.11.011
  3. Coronado GD, Jenkins CL, Shuster E, et al. Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence. Gut. 2024;73(4):622-628. doi:10.1136/gutjnl-2023-330980
  4. Data on file. Guardant Health, Inc.
  5. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74:12-49. doi: 10.3322/caac.21820
  6. American Cancer Society. Achieving 80% colorectal cancer screening rates in every community. Accessed October 18, 2023. https://nccrt.org/80-in-everycommunity-2/#1686669313593-e93793c6-cbc7
  7. 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
  8. National Cancer Institute. Cancer Stat Facts: Colorectal Cancer. Accessed May 31, 2024. https://seer.cancer.gov/statfacts/html/colorect.html
  9. National Cancer Institute. Colon Cancer Treatment (PDQ®)–Health Professional Version. Accessed June 2, 2024. https://www.cancer.gov/types/colorectal/hp/colon-treatment-pdq
  10. American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. Atlanta: American Cancer Society; 2023.
  11. Bresalier RS. Early detection of and screening for colorectal neoplasia. Gut Liver. 2009;3(2):69-80. doi: 10.5009/gnl.2009.3.2.69
  12. Jones RM, Devers KJ, Kuzel AJ, Woolf SH. Patient-reported barriers to colorectal cancer screening: A mixed-methods analysis. Am J Prev Med. 2009:38(5):508-516. doi:10.1016/j.amepre.2010.01.021
  13. Muthukrishan M, Arnold LD, Aimee SJ. Patients’ self-reported barriers to colon cancer screening in federally qualified health center settings. Prev Med Rep. 2019 May 15;15:100896. doi:10.1016/j.pmedr.2019.100896
  14. Bretthauer M, Løberg M, Wieszczy P, et al. NordICC Study Group. Effect of colonoscopy screening on risks of colorectal cancer and related death. N Engl J Med. 2022;387(17):1547-1556. doi: 10.1056/NEJMoa2208375
  15. Lin JS, Perdue LA, Henrikson NB, Bean SI, Blasi PR. Screening for Colorectal Cancer: An Evidence Update for the U.S. Preventive Services Task Force. Evidence Synthesis No. 202. AHRQ Publication No. 20-05271-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2021.
  16. Quintero E, Castells A, Bujanda L. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012;366(8):697-706. doi: 10.1056/NEJMoa1108895
  17. Jensen CD, Corley DA, Quinn VP, et al. Fecal immunochemical test program performance over 4 rounds of annual screening. Ann Intern Med. 2016;164(7):456-463. doi: 10.7326/M15-0983
  18. Oluloro A, Petrik AF, Turner A, et al. Timeliness of colonoscopy after abnormal fecal test results in a safety net practice. J Community Health. 2016;41(4):864-870. doi: 10.1007/s10900-016-0165-y.
  19. Binefa G, Garcia M, Milà N, et al. Colorectal cancer screening programme in Spain: Results of key performance indicators after five rounds (2000-2012). Sci Rep. 2016;6:19532. doi: 10.1038/srep19532
  20. Idigoras I, Arrospide A, Portillo I, et al. Evaluation of the colorectal cancer screening programme in the Basque Country (Spain) and its effectiveness based on the Miscan-colon model. BMC Public Health. 2017;18(1):78. doi: 10.1186/s12889-017-4639-3
  21. Bretagne JF, Piette C, Cosson M, Durand G, Lièvre A. Switching from guaiac to immunochemical faecal occult blood test increases participation and diagnostic yield of colorectal cancer screening. Dig Liver Dis. 2019;51(10):1461-1469. doi: 10.1016/j.dld.2019.05.004
  22. Akram A, Juang D, Bustamante R, et al. Replacing the guaiac fecal occult blood test with the fecal immunochemical test increases proportion of individuals screened in a large healthcare setting. Clin Gastroenterol Hepatol. 2017;15(8):1265-1270.e1. doi: 10.1016/j.cgh.2017.01.025
  23. Singal AG, Gupta S, Sugg Skinner C, et al. Effect of colonoscopy outreach vs fecal immunochemical test outreach on colorectal cancer screening completion: a randomized clinical trial. JAMA. 2017;318(9):806-815. doi: 10.1001/jama.2017.11389
  24. Nielson CM, Vollmer WM, Petrik AF, Keast EM, Green BB, Coronado GD. Factors affecting adherence in a pragmatic trial of annual fecal immunochemical testing for colorectal cancer. J Gen Intern Med. 2019;34(6):978-985. doi: 10.1007/s11606-018-4820-0
  25. Forsberg A, Westerberg M, Metcalfe C, et al. SCREESCO Investigators. Once-only colonoscopy or two rounds of faecal immunochemical testing 2 years apart for colorectal cancer screening (SCREESCO): Preliminary report of a randomised controlled trial. Lancet Gastroenterol Hepatol. 2022;7(6):513-521. doi: 10.1016/S2468-1253(21)00473-8
  26. Conroy K. Exact Sciences. 36th Annual JP Morgan Healthcare Conference; 9 January 2018; San Francisco, California 2018.
  27. Weiser E, Parks PD, Swartz RK, et al. Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening: Real-world data from a large cohort of older adults. J Med Screen. 2021;28(1):18-24. doi:10.1177/0969141320903756
  28. Miller-Wilson L, Finney Rutten LJ, Van Thomme J, Ozbay B, Limburg PJ. Cross-sectional adherence with the multitarget stool DNA test for colorectal cancer screening in a large, national study of insured patients. Abstract presented at: 2021 Gastrointestinal Cancers Symposium; January 22, 2021.
  29. 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