Nearing completion of a Food and Drug Administration filing, Freenome unveils significant liquid biopsy data findings
By Nick Paul Taylor, published on April 5, 2024
In a recent development, Freenome's colorectal cancer (CRC) blood test has shown promising results in early-stage cancer detection, but its performance in detecting precancerous lesions has been less impressive. This comparative overview examines the efficacies of leading non-invasive CRC screening tests from Freenome, Exact Sciences (Cologuard Plus), and Guardant Health.
1. Freenome’s Blood-Based CRC Test
Freenome's multiomics blood test leverages cfDNA methylation patterns, targeted mutations, and protein biomarkers to detect CRC. The test demonstrates a sensitivity of around 70-80% for early-stage CRC, but its performance in detecting precancerous lesions is less robust, with sensitivities ranging from 30-40% for advanced adenomas. Tests show specificity around 90-95%, minimizing false positives. The blood-based format allows for easier patient compliance compared to stool tests but currently trails stool-based tests in precancerous lesion detection.
2. Exact Sciences’ Cologuard Plus (stool-based)
Exact Sciences' Cologuard Plus is a stool DNA test that analyses aberrant methylation markers, mutant DNA (e.g., KRAS mutations), and hemoglobin detection. This test shows the highest sensitivity among non-invasive tests for advanced adenomas at 42-50%, a step up from the original Cologuard’s ~42%. Sensitivity is very strong, approximately 85-92% for early-stage CRC. High specificity, typically around 87-90%, ensures few false positives. Stool tests like Cologuard Plus remain a gold standard for non-invasive CRC screening, especially for combined cancer and precancerous lesion detection.
3. Guardant Health’s CRC Tests
Guardant Health’s CRC tests focus on early cancer detection via cfDNA methylation and fragmentomics. Their early detection assay for CRC is emerging, but published sensitivities for advanced adenomas are generally lower, in the 20-30% range. Early-stage CRC sensitivities reported in studies range widely from 65-75%, with ongoing improvements. High specificity in clinical validation (>90%) ensures few false positives. Guardant’s test is still under evaluation for broad CRC screening but offers a promising non-invasive option, with a focus on integrating multi-analyte approaches.
Summary Comparison:
| Feature | Freenome (Blood) | Exact Sciences Cologuard Plus (Stool) | Guardant Health (Blood) | |----------------------------------|-----------------------------|---------------------------------------|---------------------------------| | Sensitivity Advanced Adenomas | ~30-40% | ~42-50% | ~20-30% | | Sensitivity Early-Stage CRC (I/II)| ~70-80% | ~85-92% | ~65-75% | | Specificity | ~90-95% | ~87-90% | ~90+% | | Sample Type | Blood | Stool | Blood | | Clinical Use Status | Emerging/Clinical Validation| FDA Approved | Emerging/Clinical Validation | | Notes | Easier for patients, improving precancer detection | Most sensitive for precancerous lesions and cancer, but stool-based | Promising multi-omics, still maturing |
Conclusion
Cologuard Plus remains the most sensitive test for detecting both precancerous lesions and early-stage colorectal cancer, despite requiring stool samples. Freenome’s blood test is a promising alternative with good early cancer detection and improving precancerous lesion sensitivity, offering ease of use. Guardant Health’s assays are also advancing, with strengths in early-stage cancer detection through blood but currently less sensitive for precancerous lesions. Each test’s utility may be influenced by patient preference, clinical context, and evolving evidence from ongoing trials.
For more granular data, specific pivotal studies or trials can be referenced. The trial enrolled approximately 49,000 people aged 45 to 85 years with an average risk of colorectal cancer. The test achieved a higher sensitivity (63.5%) for stage 1 cancer in the pre-specified analysis. Exact Sciences' stool-based Cologuard Plus has reported higher sensitivity for advanced precancerous lesions (43%) compared to Freenome's blood test. No specific data was provided regarding Freenome's blood test's sensitivity for detecting stage 1 cancer in cross-trial comparisons with Exact Sciences' Cologuard Plus. Freenome has published data from a pivotal trial of its blood-based test for colorectal cancer in JAMA. The article is categorized under Clinical Trials and Diagnostics. In the evaluable cohort of around 27,010 participants, Freenome reported 79.2% sensitivity for colorectal cancer and 91.5% specificity for advanced colorectal neoplasia compared to colonoscopy.
- In the realm of medical-health analytics, the FDA has granted approval for Exact Sciences' Cologuard Plus, a stool-based test, for colorectal cancer (CRC) screening, thanks to its robust performance in detecting both early-stage CRC and precancerous lesions.
- The artificial intelligence (AI) application in medtech has shown promising results in the field of health-and-wellness, with Freenome's blood test utilizing multiomics analysis, cfDNA methylation patterns, targeted mutations, and protein biomarkers for CRC diagnostics.
- The news of Guardant Health's emerging blood-based CRC tests has garnered attention in the scientific community, as they focus on early cancer detection via cfDNA methylation and fragmentomics, alongside a promising concentration on integrating multi-analyte approaches for improved sensitivities.
- Current comparative analysis indicates that the sensitivities for advanced adenomas in Freenome's blood test are less robust than stool-based tests like Cologuard Plus (42-50% compared to 30-40%).
- Researchers have been analyzing the effectiveness of these non-invasive CRC screening tests, with some recent studies suggesting that, while Freenome's blood-based test is showing improvement in precancerous lesion detection, it still lags behind stool-based tests like Cologuard Plus in this area.
