FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Exact Sciences’ Colorectal Cancer Test Gets Expanded Indication

Sept. 25, 2019
A A

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.

View today's stories