Freenome's Pivotal Colorectal Cancer Blood Test Data Published in JAMA as FDA Filing Nears Completion

Freenome, a leading player in the liquid biopsy space, has published pivotal trial data for its blood-based colorectal cancer screening test in the Journal of the American Medical Association (JAMA). The results, which align closely with the company's preliminary data release in April 2024, mark a significant milestone as Freenome approaches the completion of its premarket approval (PMA) submission to the U.S. Food and Drug Administration (FDA).

Trial Results and Performance Metrics

The JAMA-published study enrolled nearly 49,000 participants aged 45 to 85 years with average colorectal cancer risk. Among the 27,010 evaluable participants, Freenome's blood test demonstrated a sensitivity of 79.2% for colorectal cancer detection and a specificity of 91.5% for advanced colorectal neoplasia when compared to colonoscopy results.

The test's performance varied across cancer stages, with 57.1% sensitivity for stage 1 cancers and 100% sensitivity for stage 4 tumors. However, the detection of advanced precancerous lesions proved challenging, with a sensitivity of only 12.5%, falling short of the pre-specified threshold for this secondary endpoint.

A pre-specified analysis, weighted to match the U.S. population's age and sex distribution, showed slightly improved results. In this analysis, the test achieved 63.5% sensitivity for stage 1 cancers and demonstrated sensitivities of 13.7% and 30.5% for advanced precancerous lesions and high-grade dysplasia/carcinoma in situ, respectively.

Regulatory Progress and Market Implications

Freenome aims to complete all modules of its PMA submission to the FDA by mid-2025. If approved, the test's market adoption will likely hinge on recommendations from the U.S. Preventive Services Task Force, an expert group that sets standards for preventive services such as cancer screenings.

The publication of these results has implications beyond Freenome, potentially impacting competitors like Exact Sciences and Guardant Health. While Freenome's blood test shows promise in cancer detection, it appears less effective at identifying precancerous cells compared to Exact Sciences' stool-based Cologuard Plus, which has reported 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia.

Recognizing the need for improvement, Freenome has stated its commitment to enhancing the detection of advanced precancerous lesions through "a test versioning strategy focused on assay and algorithm improvements."

As the field of liquid biopsy continues to evolve, the race to develop accurate, non-invasive screening methods for colorectal cancer intensifies. With early detection crucial for improving survival rates, the potential impact of these emerging technologies on patient outcomes and healthcare practices remains a focal point for the industry and medical community alike.