The U.S. Food and Drug Administration (FDA) has approved Exact Sciences' Cologuard Plus, a next-generation multitarget stool DNA test, for colorectal cancer (CRC) screening in adults aged 45 years and older who are at average risk for the disease. This approval marks a significant advancement in non-invasive CRC screening, offering improved sensitivity and specificity compared to existing methods. The company anticipates launching the test in 2025, with Medicare coverage and inclusion in relevant guidelines.
Enhanced Performance of Cologuard Plus
The FDA's decision was based on data from the pivotal BLUE-C study, a large prospective trial involving over 20,000 adults. The study evaluated the performance of Cologuard Plus against an independent fecal immunochemical test (FIT). Key findings from the BLUE-C study include:
- Sensitivity: Cologuard Plus demonstrated 95% overall sensitivity for detecting colorectal cancer and 43% sensitivity for advanced precancerous lesions.
- Specificity: The test showed 94% specificity, minimizing false positives.
- Superiority to FIT: Cologuard Plus significantly outperformed FIT in detecting overall CRC, treatable-stage CRC (stages I-III), high-grade dysplasia, and advanced precancerous lesions.
Thomas F. Imperiale, MD, professor of medicine at the Indiana University School of Medicine and principal investigator for the BLUE-C study, emphasized the importance of early detection, stating, "To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable – and find advanced precancers, which can prevent cases of this cancer."
Clinical Significance and Impact
Colorectal cancer is the second deadliest cancer in the United States, yet it is often considered one of the most preventable forms of cancer. The improved performance of Cologuard Plus is expected to enhance screening rates and outcomes by detecting cancer early and reducing the number of false positives, which can lead to unnecessary colonoscopies.
Kevin Conroy, Chairman and CEO of Exact Sciences, noted, "Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients... This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening."
BLUE-C Study Details
The BLUE-C study (NCT04144738) was a multi-center, prospective trial designed to evaluate the performance of Cologuard Plus and Exact Sciences’ blood-based colorectal cancer screening test. The study used colonoscopy as a reference method and included a diverse cohort, with approximately 40% of participants identifying as Hispanic or Latino, Black, Asian, American Indian or Alaska Native, or Pacific Islander. This diversity ensures the relevance of the findings across various racial and ethnic groups.
Test Features and Availability
Developed in collaboration with Mayo Clinic, Cologuard Plus features novel biomarkers and improved laboratory processes. Enhanced sample stability components provide patients with more time to return their sample to the lab, increasing the valid result rate. Exact Sciences is preparing for the commercialization of Cologuard Plus, with an expected launch in 2025, supported by Medicare coverage and inclusion in the U.S. Preventive Services Task Force (USPSTF) guidelines.
