FDA approves Cologuard Plus, a next-generation stool DNA test with 95% cancer sensitivity

Abbott Laboratories/Cologuard

The FDA approved Exact Sciences' Cologuard Plus for average-risk adults aged 45 and older. In the BLUE-C study it caught 95% of colorectal cancers and 43% of advanced precancerous lesions at 94% specificity, beating a standard blood-only stool test (FIT).

• Next-generation multitarget stool DNA test from Exact Sciences.
• BLUE-C: 95% cancer sensitivity, 43% for advanced precancerous lesions, 94% specificity.
• Beat a standalone FIT (blood-only stool test) run on the same participants.
• Launch with Medicare coverage planned for 2025.