FDA Advisers Back Approval for Guardant's Blood-Based Cancer Test

 Advisers to the U.S. Food and Drug Administration on Thursday recommended for the approval of Guardant Health's blood test to detect a cancer that begins in the colon or rectum.

The panel voted seven-to-two in favor of benefits outweighing risks when using the test called Shield for colorectal cancer (CRC).

If approved, Shield could become the second blood-based test for CRC diagnosis in the United States after Epigenomics' Epi proColon, which was approved by in 2016.

CRC occurs in about 150,000 patients in the U.S. annually and is the second-leading cause of cancer fatalities in the country, with more than 50,000 deaths each year, according to the FDA.

https://www.usnews.com/news/top-news/articles/2024-05-23/u-s-fda-advisers-back-approval-for-guardants-blood-based-cancer-test