Freenome's Enhanced Colorectal Cancer Blood Test Achieves Significant Sensitivity Improvements

Freenome Enhances Sensitivity of Colorectal Cancer Screening

Freenome, a pioneer in early cancer detection technology, has announced significant improvements in its blood-based test for colorectal cancer (CRC). With recent data presented at the ASCO Gastrointestinal Cancers Symposium in San Francisco, the company's updated SimpleScreen CRC test achieved an astounding 85% sensitivity for CRC and a notable 22% for advanced precancerous lesions (APLs), while maintaining a specificity of 90%.

The advancements stem from a major validation study involving nearly 1,000 samples, where the newer iteration of the SimpleScreen test was directly compared with its predecessor, currently under review by the FDA. This comprehensive study meticulously controlled for biological variations, allowing a credible evaluation of how the upgrade in the assay performed in detecting cancers and precursors compared to the earlier version.

Key Improvements in Detection Rates

The enhancements in the test's performance are attributed to several upgrades in its assay design. These upgrades have optimized critical components such as reagents and workflows, resulting in improved detection rates and a significant reduction in the limit of detection. The updated test reflects a 2.6-fold decrease in the threshold for detecting APLs with high-grade dysplasia, marking a crucial step in identifying precancerous conditions earlier than ever before.

Further analysis indicated that these enhancements could lead to significant positive impacts on patient outcomes. The updated test is projected to contribute to a 9% reduction in lifetime CRC cases and a 10% decrease in CRC-related deaths, emphasizing its potential in saving lives through proactive screening and early intervention.

Freenome's Future Prospects

Aaron Elliott, Ph.D., CEO of Freenome, expressed enthusiastic confidence regarding the new developments. He emphasized that the results presented at the ASCO GI demonstrate the company's commitment to continuous improvement in cancer detection methodologies. Elliott stated, "The versioning strategy we have deployed shows our capability to achieve significant advancements in test performance, paving the way for a future filled with multiple robust blood-based cancer screening tests."

The data for the enhanced CRC test will undergo further analysis during a poster session scheduled for January 10, 2026, to be presented by Aasma Shaukat, M.D., M.P.H., a leading physician at NYU Grossman School of Medicine and a principal investigator in the PREEMPT CRC study.

Freenome's cutting-edge multiomics platform leverages AI and machine learning to analyze a variety of biomarker classes including genomics, epigenomics, and proteomics. This unique approach allows researchers to discern the earliest biological indicators of cancer within the bloodstream, a crucial factor in developing the SimpleScreen CRC test, which can identify specific methylation signatures in tumor-derived cell-free DNA with exceptional precision.

As Freenome moves ahead with its plans for further clinical validations and anticipated FDA submissions, the company remains steadfast in its mission. With the company's eye set on launching a range of blood-based cancer screening tests, Freenome is firmly positioned to capitalize on its advancements in early detection technologies, aiming to dramatically reduce cancer's impact at its most treatable stages.

Freenome’s commitment to innovation is matched by their ongoing work to refine their AI/ML algorithms, with findings on these enhancements expected to be released in future studies, signaling an exciting time in the field of cancer detection.

About Freenome

Freenome is dedicated to early cancer detection and utilizes blood tests to identify cancer when it is still treatable. Recognizing the complexity of the disease's variances, Freenome employs a multiomics approach complemented by advanced artificial intelligence and machine learning methodologies to catch even the slightest signals of cancer onset before more severe symptoms arise.