Shield ™ Early CRC Detection

Guardant Health is a leading precision oncology company in the United  States that has developed the first FDA-approved blood test for  comprehensive genomic analysis of all solid tumors.

• Colorectal cancer (CRC) remains the second leading cause of cancer-related deaths in the United States.
• Approximately 150,000 people are diagnosed with colorectal cancer in the United States each year.
• Cancer screening is an effective method for detecting colorectal cancer early, when it is most treatable.
• Over 75% of individuals who died from colorectal cancer between 2006  and 2012 were not regularly screened. The 5-year survival rate improves  significantly when colorectal cancer is detected at an early stage:Early stage (I-II): 90%
  Late stage (IV): 14%
  

The Shield test employs a multimodal approach, integrating genomics,  epigenomics, and proteomics, to detect signals of colorectal cancer in  the blood, including circulating tumor DNA (ctDNA) released by tumors.

In validation studies, Shield demonstrated a sensitivity of 91% for  colorectal cancer and a sensitivity of 20% for advanced adenomas, with a  specificity (true negative rate) of 92% in normal cases.

ECLIPSE is a registered study involving over 12,750 patients, aiming  to further validate the effectiveness of this technology in detecting  early signs of colorectal cancer in average-risk adults. The results are  expected to be published in 2022.

Shield is a laboratory-developed test (LDT) designed to complement  current recommended colorectal cancer screening methods rather than replace them.

References:

• Centers for Disease Control and Prevention. Use of Colorectal Cancer Screening. https://www.cdc.gov/cancer/colorectal/statistics/use-screening-tests-BRFSS.htm. Accessed May 1, 2022.
• 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
• 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 Comm. 2017;10:27-31. doi:10.1016/j.ctarc.2016.12.004
• 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
• 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
• 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
• Proportion ranking LUNAR-2 as top CRC screening preference*, Overall N=299, GH Internal LUNAR2 Patient Research. www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html Accessed online Feb 5, 2021.
• Chakrabarti S, Peterson C, Sriram D, Amit Mahipal A, et al. Early stage colon cancer: Current treatment standards, evolving paradigms, and future directions. World J Gastro Oncol. 2020 Aug 15; 12(8): 808–832.
• American Cancer Society: Colorectal Cancer Facts & Figured 2020-2022. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf. Accessed online Feb 5, 2021.
• Rich T, Raymond V, Lang K. Where are we today? Efforts to understand strategies and barriers to physician issuance of a recommendation for colorectal cancer screening: a systematic review. Gastroenterology. 2020;158(6 suppl 1): S-918. doi:10.1016/S0016-5085(20)32981-4.
• 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.