www.fdanews.com/articles/192840-exact-sciences-colorectal-cancer-test-gets-expanded-indication
Exact Sciences’ Colorectal Cancer Test Gets Expanded Indication
September 24, 2019
The FDA approved Exact Sciences’ noninvasive colorectal cancer screening test, Cologuard, for eligible patients aged 45 years and older.
The at-home diagnostic test’s new indication expands the screening age by five years during a time when incidences of colorectal cancer are rising in patients under 50.
Cologuard is a stool DNA-based colorectal cancer screening test for average-risk individuals. The test uses a biomarker panel, which analyzes a stool sample for 10 DNA markers.