FDA Approves Cologuard Plus for Colorectal Cancer Screening

The FDA has recently approved Cologuard Plus, a multitarget stool DNA test, for the detection of colorectal cancer (CRC) and advanced precancerous lesions in adults aged 45 years and older who are at average risk. This approval provides a significant advancement in non-invasive colorectal cancer screening.

Key Findings from the BLUE-C Trial The approval of Cologuard Plus was based on results from the BLUE-C trial (NCT04144738), which highlighted its superior performance compared to traditional screening methods. The study revealed:

• 93.9% Sensitivity for detecting colorectal cancer.

• 43.4% Sensitivity for advanced precancerous lesions.

• 90.6% Specificity for advanced neoplasia.

These results underscore the test's ability to detect both treatable-stage cancers and precancerous conditions earlier, potentially saving lives through timely intervention.

Superiority Over Traditional Screening

Cologuard Plus demonstrated significant superiority over an independent fecal immunochemical test (FIT) in several areas:

1. Overall sensitivity for colorectal cancer.

2. Sensitivity for treatable-stage colorectal cancer.

3. Sensitivity for advanced precancerous lesions.
   

This performance reflects its multitarget approach, which detects DNA alterations and other biomarkers associated with colorectal neoplasia, surpassing the capabilities of FIT tests that focus solely on blood in stool.

Implications for Public Health

The approval of Cologuard Plus offers a valuable alternative for individuals seeking non-invasive CRC screening. With CRC being the second leading cause of cancer-related deaths in the U.S., increased accessibility to effective screening methods like Cologuard Plus could reduce mortality rates by enabling earlier detection and treatment.

Next Steps

Healthcare providers are encouraged to consider Cologuard Plus for patients meeting eligibility criteria and to discuss its benefits and limitations compared to other screening options. As awareness grows, this test has the potential to increase compliance with CRC screening recommendations, especially among populations hesitant about invasive procedures like colonoscopy.

For more detailed information, refer to the FDA approval documents or the BLUE-C trial publication.