FDA APPROVED FOR COLORECTAL CANCER (CRC) SCREENING

Make colorectal cancer screening easy with Shield

Healthcare Professionals: Sign up to offer Shield™ in your practice

Patients, if you're looking for more information on Shield blood test, CLICK HERE.

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For US healthcare providers only.

Why offer your patients a CRC screening blood test?

3 out of 4

3 out of 4

people who died of CRC were not up to date with screening2

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

83%

overall CRC sensitivity

90%

specificity

tube

Of the first 20,000 patients offered the Shield LDT,

9 out of 10 patients

completed screening with Shield‡

*Patients had no prior diagnosis of CRC, inflammatory bowel disease, or hereditary predisposition to CRC (eg, Lynch syndrome)

†The clinical validation cohort included over 10,000 patients. 7861 patients were included in the final clinical validation cohort

‡Internal data on file, March 2024. Data from real-world clinical settings. Data based on LDT usage of Shield, which has not been cleared or approved by the FDA

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.

*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

†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

  1. References:
  2. American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. Atlanta: American Cancer Society; 2023
  3. 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
  4. 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 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
  6. 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
  8. 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.
  9. 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
  10. 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
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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.2017.01.02
  16. 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
  17. 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
  18. 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
  19. Forsberg A, Westerberg M, Metcalfe C, et al. SCREESCO Investigators. Once-only colonoscopy or two rounds of fecal 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
  20. Conroy K. Exact Sciences. 36th Annual JP Morgan Healthcare Conference; 9 January 2018; San Francisco, California 2018.
  21. 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
  22. 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.
  23. 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: 10.100
  24. 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
  25. Chung DC, Gray DM II, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening. N Engl J Med. 2024;390(11):973-983. doi:10.1056/NEJMoa2304714