Freenome releases significant liquid biopsy data, with FDA application nearing finalization
In the realm of clinical trials and diagnostics, Freenome's colorectal cancer blood test, known as Shield, has recently been under scrutiny. The test, while offering the convenience of a blood-based screening, has shown a sensitivity for colorectal cancer detection ranging from 79.2% to 83%. However, its sensitivity for detecting advanced precancerous lesions is notably lower, around 12.5% to 16.4%.
Published in JAMA, a pre-specified analysis of the trial data reveals that the test's sensitivity for the detection of stage 1 cancer is 57.1%, increasing to 63.5% in the pre-specified analysis. Yet, it falls short in detecting early-stage precancerous lesions, a critical area for early intervention.
In contrast, Exact Sciences’ Cologuard Plus, a stool DNA plus fecal immunochemical test, outperforms Freenome's blood test. Cologuard Plus boasts a sensitivity of approximately 95% for colorectal cancer and about 43% for advanced adenomas, which are precancerous lesions. This higher sensitivity is significant for cancer prevention, as early detection and removal of precancerous adenomas play a crucial role in reducing cancer incidence.
| Test | Colorectal Cancer Sensitivity | Advanced Precancerous Lesions Sensitivity | |--------------------|-------------------------------|-------------------------------------------| | Freenome (blood) | 79–83% | 12.5–16.4% | | Cologuard Plus (stool DNA + FIT) | 95% | 43% |
The lower sensitivity of blood-based tests for precancerous lesions remains a significant limitation compared to stool-based tests like Cologuard Plus, which provide higher accuracy for early detection and prevention.
The Freenome trial, which enrolled almost 49,000 people aged 45 to 85 years, has met its primary endpoints. Freenome is now working to improve the detection of advanced precancerous lesions through a test versioning strategy focused on assay and algorithm improvements.
The five-year survival rate for localized colon and rectal cancer is around 90%, while it is below 20% for cancer that has spread to distant parts of the body. Early detection and intervention are key to improving these survival rates, and while Freenome offers a step in the right direction, it appears that stool-based tests like Cologuard Plus may still be the preferred choice for early detection and prevention of colorectal cancer.
[1] Freenome Data Reveals Moderate Sensitivity for Colorectal Cancer Detection [2] Cologuard Plus Outperforms Freenome in Detecting Advanced Precancerous Lesions [3] Freenome's Blood Test Struggles to Meet Clinical Acceptance Criteria for Precancerous Lesions Detection
- The analysis of Freenome's colorectal cancer blood test, Shield, in the realm of clinical trials and diagnostics suggests a sensitivity of 57.1% for stage 1 cancer detection, but falls short in detecting early-stage precancerous lesions, a critical area for early intervention.
- In contrast, Exact Sciences’ Cologuard Plus, a stool DNA plus fecal immunochemical test, outperforms Freenome's blood test, with a sensitivity of approximately 95% for colorectal cancer and about 43% for advanced adenomas, which are precancerous lesions.
- The lower sensitivity of blood-based tests like Freenome's for precancerous lesions remains a significant limitation compared to stool-based tests like Cologuard Plus, which provide higher accuracy for early detection and prevention.
- News articles, such as the one titled 'Freenome Data Reveals Moderate Sensitivity for Colorectal Cancer Detection,' discuss the limitations of Freenome's test in detecting precancerous lesions, while reports like 'Cologuard Plus Outperforms Freenome in Detecting Advanced Precancerous Lesions' highlight Cologuard Plus' superior performance in this regard.
- As the FDA continues to reflect on these findings in the context of medical-conditions like cancer and health-and-wellness, it is evident that the scientific community and medtech industries might need to focus more on improving diagnostics and analytics for early detection and prevention of colorectal cancer, particularly in the detection of precancerous lesions.
