[獲FDA批准] Shield ™ 早期大腸癌篩查

Guardant Shield™已在2024年7月29日獲得美國食品藥物管理局(FDA)批准用於篩查45歲及以上、對該疾病風險平均的成年人的大腸癌（CRC）。

 

 

Guardant Health是美國一家領先的精準腫瘤學公司，開發出首個獲得FDA批准的血液檢測，可對所有實體癌症進行全面基因組分析。

 

• 大腸癌（CRC）仍然是美國癌症相關死亡的第二大原因。
• 每年約有15萬人在美國被診斷出大腸癌。
• 癌症篩查是檢測大腸癌的有效方法，可以在最易治療時期早期發現。
• 在2006年至2012年期間死於大腸癌的人中，超過75％的人未進行定期篩查。當大腸癌在較早階段檢測出時，5年生存率有所提高：
  • 早期（I-II期）為90％
  • 晚期（IV期）為14％。

 

• 該測試採用多模態方法，整合基因組學、表觀基因組學和蛋白質組學，可以在血液中檢測到大腸癌的信號，包括腫瘤釋放的DNA，稱為循環腫瘤DNA（ctDNA）。
• 在驗證研究中，Shield顯示出對大腸癌的敏感性為91％，對晚期腺瘤的檢測敏感性為20％，在正常病例中的特異性（真陰性率）為92％。
• ECLIPSE是一項註冊研究，涉及超過12,750名患者，旨在進一步驗證這項技術在檢測平均風險成年人早期大腸癌徵兆方面的效果，預計將於2022年公布結果。
• Shield是一項實驗室開發的檢測（LDT），旨在作為當前推薦的大腸癌篩查方法的補充，而不是替代品。

 

參考資料

 

• 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.