FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option
The FDA's Molecular and Clinical Genetics Panel has strongly recommended the approval of Guardant Health's Shield™ blood test for colorectal cancer (CRC) screening in adults aged 45 and older at average risk. The panel's vote was 8 to 1 for safety, 6 to 3 for effectiveness, and 7 to 2 for benefits outweighing risks. Shield aims to improve CRC screening rates by offering a non-invasive alternative to stool-based tests. Shield demonstrated 83% sensitivity and 90% specificity for advanced neoplasia in the pivotal ECLIPSE study, aligning with existing non-invasive tests. The FDA is expected to make its decision later this year.
- FDA panel strongly recommends Shield™ blood test approval.
- Panel votes: 8 to 1 on safety, 6 to 3 on effectiveness, 7 to 2 on benefits outweighing risks.
- Shield aims to increase CRC screening rates by offering a non-invasive option.
- Shield demonstrated 83% sensitivity and 90% specificity for advanced neoplasia.
- Shield aligns with existing stool-based test performance.
- Potential to reduce preventable CRC deaths.
- FDA panel's recommendations are non-binding; final approval is uncertain.
- Effectiveness vote was not unanimous (6 to 3).
- Potential risks associated with the test, as acknowledged by the panel.
Insights
Colorectal cancer (CRC) remains one of the most deadly cancers in the U.S., but early detection significantly improves survival rates. The strong recommendation from the FDA's advisory committee for the approval of Shield™ blood test is a substantial development in the field of oncological diagnostics. This test promises a new, non-invasive way to screen for CRC, which could lead to higher screening rates and early detection. Traditional stool-based tests, while effective, often face low adherence due to the nature of the test. Shield, as a simple blood draw, offers a more acceptable and less invasive option, potentially increasing participation rates in CRC screening.
The performance metrics of Shield, with an 83% sensitivity and 90% specificity for advanced neoplasia, are within the range of existing stool-based tests. Sensitivity refers to the test's ability to correctly identify those with the disease, while specificity measures the ability to correctly identify those without the disease. These metrics are important in evaluating the effectiveness and reliability of a screening method. Any increase in the screening rate can help reduce CRC mortality by catching the disease at an earlier, more treatable stage.
From a financial perspective, the advisory committee’s recommendation for Shield™ blood test represents a potential market expansion for Guardant Health, Inc. The company could see a significant boost in revenue if the test receives FDA approval and becomes an accepted option for CRC screening. Medicare coverage, which Shield is on track to meet, is particularly important as it ensures broader accessibility and affordability for patients, potentially driving higher adoption rates.
The market for CRC screening is substantial given that one in three eligible Americans is not currently being screened. By offering a more convenient and less invasive option, Shield may capture a significant portion of this underserved market. Additionally, the positive vote results (8 to 1 for safety, 6 to 3 for effectiveness and 7 to 2 for benefits outweighing risks) provide a strong indicator of the test's potential success upon approval, reinforcing investor confidence.
The development of Shield™ blood test for CRC screening addresses a critical unmet need in the market—higher adherence to screening protocols due to a less invasive testing method. Current non-invasive stool-based tests, though effective, suffer from low compliance primarily due to the discomfort and inconvenience associated with sample collection. By providing a blood test alternative, Guardant Health is poised to disrupt the current CRC screening landscape positively.
Additionally, the public health implications are significant. Increasing CRC screening adherence rates can lead to earlier detection and treatment, ultimately reducing mortality rates. The advisory committee’s strong support for the test indicates confidence in its clinical efficacy and safety, which can further bolster market acceptance and integration into routine practice. This innovation could set a precedent for other types of cancer screenings, encouraging the development of similar non-invasive tests.
- The advisory committee offers valuable non-binding recommendations for the FDA
- Blood test offers a convenient non-invasive screening option that overcomes barriers associated with current non-invasive screening tests
- Shield remains on track to become the first FDA-approved blood test that meets performance requirements for Medicare coverage1
The recommendation signals the advisory committee panel's consensus on Shield's safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks. The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions. The FDA is expected to decide whether to approve Shield later this year.
“The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk,” said AmirAli Talasaz, co-CEO of Guardant Health. “Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths.”
The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication. They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.
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The panel’s recommendation is based on Guardant’s premarket approval (PMA) application for Shield, including the results of the pivotal ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study, published in the March 2024 issue of The New England Journal of Medicine, showed that Shield demonstrated
For more information about Shield for CRC screening, visit BloodBasedScreening.com.
About the Shield test
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 Blood Collection Kit. Shield is intended for colorectal cancer screening in individuals at average risk of the disease, age 45 years or older. Patients with an “Abnormal Signal Detected” may have colorectal cancer or advanced adenomas and should be referred for colonoscopy evaluation. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. The test is performed at Guardant Health, Inc.
About Guardant Health
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2023, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.
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 21, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
3. American Cancer Society. Survival Rates for Colorectal Cancer. Accessed online May 21, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html
4. National Colorectal Cancer Roundtable.
5. 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.
6. Denberg TD, Melhado TV, Coombes JM, et al. Predictors of Nonadherence to Screening Colonoscopy. J Gen Intern Med. 2005;20(11):989-995.
7. 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.
8. 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.
9. Doubeni, CA, 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.
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Source: Guardant Health, Inc.
FAQ
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