The FDA approved a blood test developed by Guardant Health for the detection of colorectal cancer. The test, known as Shield, had been available in the U.S. as a laboratory-developed test since 2022.

The FDA's approval brought Shield closer to becoming the first blood test for colorectal cancer (CRC) screening eligible for Medicare insurance coverage for older adults. The test was approved for use in adults aged 45 years and older.

Shield's approval marked the second for a blood-based test for CRC screening in the U.S. after Epigenomics' Epi proColon, which was approved in 2016 but failed to meet the government's 74% or higher sensitivity criteria for Medicare coverage.

According to FDA documents, a study showed that Guardant's Shield test detected 83% of colorectal cancers. Colonoscopy remained the gold standard test for CRC.