Exact Sciences Earns FDA Approval for Cologuard Plus

by Brian Lee

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Exact Sciences announced today that the U.S. Food and Drug Administration (FDA) approved its next-generation multitarget stool DNA test called Cologuard Plus.

“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” Exact Sciences Chairman and CEO Kevin Conroy said in a statement. “Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent.”

According to a release, the Cologuard Plus test demonstrated 95 percent overall cancer sensitivity. The original Cologuard test, which received FDA approval in 2014, was proven to find 92 percent of cancers. 

Exact Sciences said it expects to launch the Cologuard Plus test with Medicare coverage and guideline inclusion in 2025.