FDA Approves First Blood Test for Primary Colorectal Cancer Screening

The US Food and Drug Administration has approved Guardant Health’s Shield blood test for colorectal cancer (CRC) screening in adults 45 years of age and older at average risk for the disease.¹

Announced on July 29, 2024, the decision follows a strong recommendation for approval by an Advisory Committee panel in May 2024 and is based on results from a registrational study, ECLIPSE, enrolling more than 20,000 average-risk patients. The approval makes Shield the first blood test to be approved by the FDA as a primary screening option for CRC, and it is the first blood test for CRC screening to meet the requirements for Medicare coverage.^1,2,3

“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” Daniel Chung, MD, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a press release.¹ “The FDA's approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”

A non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood, Shield is intended as a screening test for individuals 45 years of age and older at average risk for the disease and is not intended for individuals at high risk for CRC. As described in a release from Guardant Health, primary care physicians can have patients complete a Shield test during a routine office visit, providing an alternative screening method without the special preparation, dietary changes, time, and discomfort associated with colonoscopy or stool-based tests. The Shield test can be viewed similarly to guideline-recommended non-invasive CRC screening options and a positive result raises concern for the presence of colorectal cancer or advanced adenoma and requires further colonoscopy evaluation.¹

According to the release, the Shield blood test is a culmination of more than 10 years of research and development. A laboratory-developed test was commercially introduced in 2022 and has since demonstrated an overall adherence rate of more than 90%, compared to 28-71% adherence rates with other screening methods such as colonoscopy or a stool test.¹

On May 23, 2024, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee strongly recommended FDA approval of the Shield blood test for CRC screening in adults aged 45 years and older at average risk for the disease. Specifically, they voted 8 to 1 favorably regarding the reasonable assurance of Shield’s safety, 6 to 3 favorably regarding the reasonable assurance of Shield’s effectiveness, and 7 to 2 favorably that the benefits of Shield outweigh its risks.²

The approval was based on results from 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 US, the study was conducted at more than 200 clinical trial sites in rural and urban communities across 37 states. Results from the study showed Shield demonstrated 83% sensitivity for the detection of CRC and 90% specificity for advanced neoplasia. Of note, this performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.^1,3

According to the release, 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. Guardant Health noted 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 US Preventive Services Task Force.¹

“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” AmirAli Talasaz, Guardant Health co-CEO, said in a press release.¹ “We are now getting ready to launch this test in the near future and are very excited to empower physicians with a viable blood-based screening option to tailor the screening regimen to the unique needs of their patients.”

References

1. ^{Guardant Health. Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening. July 29, 2024. Accessed July 29, 2024. https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Healths-Shield-Blood-Test-Approved-by-FDA-as-a-Primary-Screening-Option-Clearing-Path-for-Medicare-Reimbursement-and-a-New-Era-of-Colorectal-Cancer-Screening/default.aspx}
2. ^{Guardant Health. FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option. May 23, 2024. Accessed July 29, 2024. https://investors.guardanthealth.com/press-releases/press-releases/2024/FDA-Advisory-Committee-Panel-Strongly-Recommends-Approval-of-Shield-Blood-Test-for-Colorectal-Cancer-Screening-as-a-Primary-Non-Invasive-Screening-Option/default.aspx}
3. ^{Brooks, A. ECLIPSE: Blood-Based Test Shows 83% Accuracy for Detecting Colorectal Cancer. HCPLive. March 14, 2024. Accessed July 29, 2024. https://www.hcplive.com/view/eclipse-blood-based-test-shows-accuracy-detecting-colorectal-cancer}