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# Colon Cancer Blood Test Goes to Panel
- URL: https://www.fdaweb.com/colon-cancer-blood-test-goes-to-panel/
- Published: 2024-04-23T12:00:00.000Z
- Updated: 2026-09-14T14:28:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156832

*Federal Register* notice: FDA’s Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel announces a 5/23 meeting to review a Guardant Health PMA for its Shield blood test for colorectal cancer (CRC) screening. The proposed indication for use statement is as follows:

“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.”

To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-04-23/pdf/2024-08656.pdf?ref=fdaweb.com).