FDA Approves First Blood Test for Primary CRC Screening

The U.S. Food and Drug Administration (FDA) July 29 has approved the Shield blood test for colorectal cancer (CRC) screening among adults aged 45 and older who are at average risk for the disease.

In the ECLIPSE study, which evaluated the test’s performance in detecting CRC among more than 20,000 patients across the US, Shield demonstrated 83% sensitivity for the detection of CRC, 90% specificity for advanced neoplasia, and 13% sensitivity for advanced precancerous lesions.

FDA approval allows health care providers to offer the blood test along with other noninvasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.

The Shield test is not indicated for people with a personal history of colorectal cancer, adenomas, or other related cancers; or those who have been diagnosed with ulcerative colitis or Crohn’s disease, which puts those patients at higher risk for CRC. It is also not indicated for those with a family history of colorectal cancer or certain hereditary conditions, such as Lynch syndrome.

A negative result does not guarantee the absence of colorectal cancer or advanced adenoma, the test’s manufacturer, Guardant Health, stated in its announcement of the approval.

References:

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. Press release. Guardant Health; July 29, 2024. Accessed July 30, 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

Chung DC, Gray DM, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening. N Engl J Med. 2024;390:973-983 https://www.nejm.org/doi/full/10.1056/NEJMoa2304714