Next Gen Stool DNA Test Outperforms FIT in Colorectal Cancer Detection

Cologuard Plus, Exact Sciences Corp.’s (Madison, WI, USA) next-generation multi-target stool DNA test for CRC, features novel biomarkers and improved laboratory processes. In the 20,000-participant BLUE-C study, researchers determined the performance characteristics of Cologuard Plus and compared that performance to the fecal immunochemical test (FIT), a commonly used noninvasive CRC screening test. Both tests require a single stool sample analyzed in a lab, with FIT recommended yearly and stool DNA testing every three years. The study participants, asymptomatic men and women over 40, were a diverse population generally representative of racial and ethnic demographic characteristics of persons in the United States eligible for CRC screening.

In the study findings, Cologuard Plus surpassed FIT in cancer detection rates and showed greater sensitivity for advanced precancerous colon lesions, although FIT recorded a lower rate of false positives. With no polyps detected, both tests presented a 5% false positive rate. Cologuard Plus successfully met the study's goals, showcasing 94% sensitivity for CRC with 91% specificity when including non-advanced findings and 93% specificity excluding any findings. Notably, specificity increased to 96% among participants aged 45 to 54. Cologuard Plus can reduce the need for unnecessary follow-up colonoscopies by lowering the chances of a false-positive result. Exact Sciences submitted Cologuard Plus for U.S. Food and Drug Administration (FDA) approval in December 2023, with full BLUE-C results, and is gearing up for its launch in 2025, pending approval.

“We’re eager to bring an improved, noninvasive colorectal cancer screening test to patients in Cologuard Plus, as colorectal cancer remains the most preventable, yet least prevented cancer,” said Kevin Conroy, chairman and CEO of Exact Sciences.

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