Freenome's Pivotal Colorectal Cancer Blood Test Data Published in JAMA

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 initial data release in April 2024, mark a significant step towards potential FDA approval and market entry.

Trial Results and Performance Metrics

The large-scale pivotal trial enrolled nearly 49,000 individuals aged 45 to 85 years with average colorectal cancer risk. Among the 27,010 evaluable participants, Freenome's blood test demonstrated:

• 79.2% sensitivity for colorectal cancer detection
• 91.5% specificity for advanced colorectal neoplasia compared to colonoscopy
• Varying sensitivity across cancer stages: 57.1% for stage 1, rising to 100% for stage 4
• 12.5% sensitivity for advanced precancerous lesions
• 29.1% sensitivity for high-grade dysplasia and carcinoma in situ

The study met its primary endpoints, although it fell short of a secondary endpoint related to advanced precancerous lesion detection.

Regulatory Progress and Market Implications

Freenome is progressing towards regulatory approval, with plans to complete all modules of its premarket approval submission to the FDA by mid-2025. If approved, the test's adoption will likely be influenced by recommendations from the U.S. Preventive Services Task Force, an expert group that sets standards for preventive services including cancer screenings.

The performance of Freenome's blood test, particularly in early-stage cancer detection, underscores the potential impact on patient outcomes. With five-year survival rates for localized colon and rectal cancer around 90%, compared to below 20% for metastatic cases, early detection remains crucial.

Competitive Landscape and Future Developments

Cross-trial comparisons suggest that Freenome's blood-based test may be less effective at detecting precancerous cells compared to Exact Sciences' stool-based Cologuard Plus. Exact Sciences has reported 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia.

Acknowledging the need for improvement in precancerous lesion detection, Freenome has stated its commitment to enhancing test performance through "a test versioning strategy focused on assay and algorithm improvements."

As the liquid biopsy market continues to evolve, the publication of Freenome's pivotal data in JAMA represents a significant milestone in the ongoing efforts to develop non-invasive, highly accurate screening methods for colorectal cancer.