FDA approves Guardant Health’s Shield blood test as first primary CRC screening option

Guardant Health, a precision oncology company, announced the U.S. Food and Drug Administration (FDA) has approved the company’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. It is reportedly the first blood test to be approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage. 1

Colorectal cancer is the second-leading cause of cancer-related death in the U.S., even though it is highly treatable if caught early. 2 The American Cancer Society estimates that more than 150,000 people will be diagnosed with CRC in 2024 and the disease will be responsible for more than 53,000 deaths. 3 More than three out of four individuals who die from CRC are not up to date with their screening. 4 

The CRC screening rate in the U.S. is only about 59 per cent, which falls well below the National Colorectal Cancer Roundtable’s goal of 80 per cent for eligible individuals. 5 More than one out of three eligible Americans – over 50 million people – do not complete CRC screening, often due to the perception that other available options, such as colonoscopy or stool-based tests, are invasive, unpleasant or inconvenient. 6

According to the statement, the Shield blood test is the result of over ten years of research and development, including collaboration between Guardant Health and leading health organisations globally. Since the commercial introduction of the LDT (laboratory developed test) version in May 2022, the overall adherence rate for the Shield test has been more than 90 per cent, meaning more than 90 per cent of patients who were prescribed the test in a real-world clinical setting completed it. 7 In contrast, studies show only 28-71 per cent of patients who are prescribed other screening methods, such as colonoscopy or a stool test, complete them. 8-11 Primary care physicians can have patients complete a Shield test with a simple blood draw during a routine office visit, providing a convenient and more pleasant alternative screening method that doesn’t require the special preparation, dietary changes, time and discomfort associated with colonoscopy or the unpleasantness of handling stool.

The FDA decision follows a strong recommendation for approval by an Advisory Committee panel in May 2024. The approval was based on results of ECLIPSE , a 20,000+, patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Designed to reflect the diverse population of the U.S., the study was conducted at more than 200 clinical trial sites in rural and urban communities across 37 states. Results from the study, published in the March 14, 2024, issue of The New England Journal of Medicine , showed that Shield demonstrated 83 per cent sensitivity for the detection of CRC, with 90 per cent specificity for advanced neoplasia. This performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74 per cent to 92 per cent. 12

“Shield is available for eligible individuals by prescription through a doctor or other healthcare professional and is expected to be covered for eligible Medicare beneficiaries. Commercial insurance coverage for patients eligible for CRC screening will continue to expand following anticipated future guideline inclusion by the American Cancer Society and the U.S. Preventive Services Task Force (USPSTF),” informed the statement.

References:

1. The Shield test meets performance requirements for Medicare coverage under NCD 210.3.
   2. American Cancer Society. Key Statistics for Colorectal Cancer. Accessed online May 8, 2023. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
   3. American Cancer Society. Cancer Facts & Figures 2024. Atlanta: American Cancer Society; 2024.
   4. Doubeni, C, et al. Modifiable Failures in the Colorectal Cancer Screening Process and Their Association with Risk of Death. Gastroenterology. 2019 Jan; 156(1): 63–74.e6.
   5. 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.
   6. Raymond V, Foster G, Hong Y et al. Implementation of Blood-Based Colorectal Cancer Screening: Real-World Clinical Experience. ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.
   7. Denberg TD, Melhado TV, Coombes JM, et al. Predictors of nonadherence to screening colonoscopy. J Gen Intern Med. 2005;20(11):989-995.
   8. Gellad ZF, Stechuchak KM, Fisher DA, et al. Longitudinal adherence to fecal occult blood testing impacts colorectal cancer screening quality. Am J Gastroenterol. 2011;106(6):1125-1134.
   9. 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.
   10. Exact Sciences. Third quarter 2019 webcast and conference call. Updated October 29, 2019. Accessed December 17, 2021. https:/ investor.exactsciences.com/investor-relations/events-and-presentations/event-details/2019/Third-Quarter-2019-Webcast-Conference-Call/default.aspx
   11. Chung DC, Gray DM, Singh H et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med 2024;390:973-83.