BRISBANE, Calif. | July 9, 2026
Freenome, an early cancer detection company advancing blood-based cancer screening technologies, has announced positive top-line results from the pivotal clinical validation study evaluating the updated version of its SimpleScreen™ CRC blood test for colorectal cancer (CRC) screening. The updated assay successfully met all primary and secondary endpoints, demonstrating significant improvements in detecting advanced precancerous lesions (APLs) and high-grade dysplasia (HGD) while maintaining strong colorectal cancer detection performance. According to the study, the next-generation test achieved 18.2% sensitivity for advanced precancerous lesions, 41.9% sensitivity for APLs with high-grade dysplasia, and 80.4% sensitivity for colorectal cancer, with 90% specificity among individuals with no findings on colonoscopy. Modeling data further suggest that these improvements could translate into 1,582 additional life-years gained, 426 fewer colorectal cancer cases, and 143 fewer colorectal cancer deaths per 100,000 individuals screened compared with the company’s first-generation blood test. The results represent a major advancement in non-invasive cancer screening and strengthen Freenome’s strategy to expand access to earlier colorectal cancer detection through innovative multiomics technology.
Updated SimpleScreen™ CRC Test Demonstrates Improved Detection Performance
The updated SimpleScreen™ CRC test was evaluated using samples collected through the PREEMPT CRC registrational clinical study, one of the largest prospective colorectal cancer screening studies conducted to date. The study enrolled 48,995 asymptomatic, average-risk adults aged 45 to 85 years across more than 200 clinical sites, all scheduled for routine screening colonoscopy. Analysis included more than 85 patients with colorectal cancer, approximately 1,570 participants with advanced precancerous lesions, and 157 individuals with high-grade dysplasia. The updated test demonstrated substantial improvements over the original version, particularly in identifying advanced precancerous lesions, which represent critical targets for preventing colorectal cancer before malignant transformation occurs.
Investigators noted that the reported sensitivity for advanced precancerous lesions and high-grade dysplasia represents the highest performance reported to date for any non-invasive blood-based colorectal cancer screening test evaluated in a prospective registrational clinical trial, highlighting the potential clinical value of the technology in improving preventive cancer care.
Blood-Based Screening Could Expand Access to Early Cancer Detection
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Colorectal cancer remains the second-leading cause of cancer-related death in the United States, despite being one of the most preventable cancers when detected early. More than 50 million eligible adults remain overdue for recommended screening, creating a significant public health challenge. Freenome’s updated SimpleScreen™ CRC platform is designed to improve participation in colorectal cancer screening by providing a convenient blood-based alternative for individuals who may be unwilling or unable to complete traditional screening methods.
Improved detection of advanced precancerous lesions, especially those with high-grade dysplasia, is particularly important because these lesions have a much greater likelihood of progressing to invasive colorectal cancer if left untreated. Clinical modeling suggests the enhanced test could substantially reduce cancer incidence and mortality by increasing early intervention opportunities while preserving high specificity and maintaining strong colorectal cancer detection performance across multiple disease stages.
Commercial Strategy Advances Toward FDA Review and Market Launch
The encouraging clinical validation results further strengthen Freenome’s commercial strategy for SimpleScreen™ CRC. The company previously submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the first-generation version of the blood test and expects regulatory review to conclude during 2026. Following these latest findings, Freenome plans to submit a supplemental PMA for the updated next-generation assay while continuing collaboration with Abbott, which will hold exclusive commercialization rights upon FDA approval. The strategic partnership also includes ongoing multi-year research and development efforts focused on further enhancing assay performance and expanding blood-based cancer screening capabilities. Beyond colorectal cancer, Freenome continues advancing its broader multi-cancer early detection pipeline, leveraging its proprietary multiomics platform, artificial intelligence, and machine learning technologies to develop personalized blood-based screening solutions capable of identifying multiple cancers at their earliest and most treatable stages. The latest clinical milestone reinforces the company’s leadership in precision cancer screening and supports the growing role of non-invasive blood-based diagnostics in transforming preventive oncology.
Source: Freenome press release
