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FDA Approves Exact Sciences' Cologuard Plus™ for Enhanced Colorectal Cancer Screening

NextEdge Admin

05 Oct 2024

2 min 4 sec

Exact Sciences Corp. announced FDA approval for the Cologuard Plus™ test, a next-generation multitarget stool DNA test for colorectal cancer (CRC) screening. Approved for adults aged 45 and older at average risk, Cologuard Plus offers a non-invasive option with enhanced performance. The test demonstrated 95% cancer sensitivity and 43% sensitivity for advanced precancerous lesions, with 94% specificity in participants with no colonoscopy findings, based on results from the pivotal BLUE-C study.

The study, which included nearly 19,000 participants, revealed that Cologuard Plus significantly outperformed an independent fecal immunochemical test (FIT) in detecting CRC, treatable-stage CRC, and advanced precancerous lesions. Dr. Thomas F. Imperiale, principal investigator for the study, praised the test for its high sensitivity and low false positive rate, making it a strong first-line screening option for average-risk patients.

Kevin Conroy, Chairman and CEO of Exact Sciences, highlighted that Cologuard Plus improves sensitivity while reducing false positives by over 30% compared to the original Cologuard® test, which has been used more than 17 million times. With the launch expected in 2025, Cologuard Plus will be supported by Exact Sciences' ExactNexus™ technology platform and is anticipated to be covered by Medicare and included in key quality measures and USPSTF guidelines, further enhancing CRC screening access and effectiveness.