The panel voted 7-2 in favor of approving Gaurdant’s test, Shield. If the FDA does approve it, it will be the second blood-based test for colon cancer, competing with Epigenomics’ Epi proColon, which was approved in 2016.
However, the panel did raise concerns that Guardant’s test was not as accurate as colonoscopy and noted Shield detected only 13% of advanced adenomas, or precancerous tumors. Guardant’s application for Shield showed the test detected 83% of colorectal cancers, but FDA documents show Exact’s Cologuard has 92.3% sensitivity.
Colonoscopies remain the gold standard for detecting colon cancers, but blood tests are considered more convenient.
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