US FDA approves Guardant Health's blood-based cancer test

[July 29, 2024]  (Reuters) - The U.S. Food and Drug Administration on Monday approved Guardant Health's blood test to detect a cancer that starts in the colon or rectum.

The test called Shield has been available in the U.S. as a laboratory-developed test since 2022.

The FDA approval takes it a step closer to potentially becoming the first test for colorectal cancer screening to be eligible for Medicare insurance coverage for older adults.

Advisers to the FDA voted to approve the blood test in May, with the regulator allowing the use of the test for screening adults aged 45 years and older.

(Reporting by Sneha S K, Leroy Leo and Sriparna Roy in Bengaluru; Editing by Shounak Dasgupta)

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

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