FDA Panel Endorses Guardant Health's Blood Test for Colorectal Cancer Screening

The advisory committee's recommendation highlights the Shield test's potential to improve screening accessibility despite concerns over accuracy.

The FDA advisory panel voted in favor of the Shield test, citing its safety and effectiveness for average-risk adults aged 45 and older.
Guardant Health's Shield test detects colorectal cancer by identifying tumor DNA in blood samples, offering a non-invasive alternative to colonoscopies.
Clinical trials showed the Shield test has an 83% sensitivity rate for detecting colorectal cancer and 90% specificity for advanced neoplasia.
Concerns were raised about the test's lower accuracy in detecting early-stage cancers and precancerous lesions, which could lead to false negatives.
FDA approval could expand access to the Shield test, potentially increasing colorectal cancer screening rates and reducing preventable deaths.