FDA Approves First Blood Test for Primary Screening of Colorectal Cancer

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

With this decision, Shield is the first blood test to be approved as a primary screening option for CRC in line with other noninvasive screening options recommended in screening guidelines, and the first blood test to meet the performance requirements to be covered under Medicare, the company noted in a July 29, 2024, press release.

CRC is the second-leading cause of cancer-related death in the US, and over three-quarters of individuals who die from CRC are not up to date with their screening, according to the release. In the US, the CRC screening rate is approximately 59%, well below the National Colorectal Cancer Roundtable’s goal of 80% for eligible individuals. Also, more than 1 out of 3 eligible Americans do not complete CRC screening, mostly because of the belief that other options (ie, colonoscopy or stool-based tests) are invasive or inconvenient.

“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” Daniel Chung, MD, gastroenterologist, Massachusetts General Hospital, professor of medicine, Harvard Medical School, said in the release. “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.”

During a routine office visit, primary care physicians can have patients complete a Shield blood test with a simple blood draw to avoid the preparation, dietary changes, time, and discomfort associated with a colonoscopy or stool-based tests.

The decision comes after the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee met in May 2024 and strongly voted in favor of Shield’s approval. The FDA based its approval on data from the ECLIPSE trial, a prospective registrational that compared the blood test against screening colonoscopy in average-risk adults aged 45 to 84 years from more than 200 clinical trial sites across the US. Results showed that the blood test demonstrated 83% sensitivity for the detection of CRC, 90% specificity for advanced neoplasia, and 13% sensitivity for advanced precancerous lesions. Guardant stated in the release that these results were “within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.”

“This is a promising step toward making more convenient tools available to detect colorectal cancer early while it is more easily treated,” William M. Grady, MD, gastroenterologist, Fred Hutchinson Cancer Center, Seattle, Washington, said in the press statement. “The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options."

The company noted the Shield blood test will be available for all eligible patients and Medicare beneficiaries, with expansions into commercial insurance coverage following inclusion of the test in future guidelines from the American Cancer Society and the US Preventive Services Task Force.

Reference: 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. News release. Guardant Health. July 29, 2024. Accessed August 7, 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