The U.S. Food and Drug Administration (FDA) has approved Exact Sciences' Cologuard Plus test for colorectal cancer screening in adults aged 45 and older who are at average risk.

This approval is based on the pivotal BLUE-C study, which involved over 20,000 participants and demonstrated that Cologuard Plus significantly outperformed traditional fecal immunochemical tests (FIT) in sensitivity.

Specifically, the Cologuard Plus test achieved a sensitivity of 95% for detecting colorectal cancer and 43% for advanced precancerous lesions, with a specificity of 94%.

One of the key advancements of Cologuard Plus is its ability to reduce false-positive results by more than 30%, which can help minimize unnecessary follow-up colonoscopies.

Developed in collaboration with the Mayo Clinic, the Cologuard Plus test utilizes novel biomarkers and enhanced laboratory processes to improve screening accuracy.

The test incorporates enhanced sample stability, allowing patients more time to return their samples to the lab, further facilitating the screening process.

This development is crucial as approximately 60 million Americans are currently not up to date with their colorectal cancer screenings.

Colorectal cancer remains the second deadliest cancer in the United States, making early detection and improved screening rates essential.

Kevin Conroy, Chairman and CEO of Exact Sciences, emphasized that Cologuard Plus not only improves sensitivity but also significantly reduces false positives.

Dr. Thomas F. Imperiale highlighted the importance of early detection in improving colorectal cancer outcomes, noting the test's low false-positive risk.

Exact Sciences plans to launch the Cologuard Plus test in 2025, with expectations for Medicare coverage and inclusion in the U.S. Preventive Services Taskforce guidelines.

As the company prepares for commercialization, the Cologuard Plus test will be supported by their ExactNexus technology platform.