NOW FDA APPROVED FOR COLORECTAL CANCER (CRC) SCREENING

Make Colorectal Cancer Screening Easy with Shield


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


*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
  5. 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
  6. 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.
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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
  16. 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
  17. 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
  18. Conroy K. Exact Sciences. 36th Annual JP Morgan Healthcare Conference; 9 January 2018; San Francisco, California 2018.
  19. 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
  20. 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.
  21. 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
  22. 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
  23. 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