US EditionFreenome Announces JAMA Publication of Data from Pivotal Study of its Blood-Based Test for Colorectal Cancer
- On June 2, 2025, Freenome, a biotech firm based in Brisbane, California, announced in JAMA the results of its PREEMPT CRC study, which enrolled nearly 49,000 average-risk individuals between the ages of 45 and 85 across more than 200 locations in the United States.
- The study began in 2020 to validate Freenome's blood-based colorectal cancer screening test using a hybrid recruitment model designed to ensure a diverse and representative population including underserved communities.
- Analysis of data from 27,010 consecutively enrolled eligible participants demonstrated that the test fulfilled all predetermined key efficacy criteria and surpassed the sensitivity and specificity thresholds established by the Centers for Medicare & Medicaid Services for its target population.
- The test demonstrated overall colorectal cancer sensitivity of 79.2%, 100% sensitivity for adults aged 45-49, and 91.5% specificity for advanced colorectal neoplasia, with co-lead investigator Aasma Shaukat noting persistent screening barriers.
- Freenome is advancing its FDA premarket approval submission expected to complete mid-2025, and the test could increase screening rates by offering a noninvasive option aligned with its early cancer detection platform vision.
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Freenome Announces JAMA Publication of Data from Pivotal Study of its Blood-Based Test for Colorectal Cancer
– PREEMPT CRC, the largest prospective study of its kind, met all primary efficacy endpoints and surpassed CMS coverage requirements for sensitivity and specificity in the intended use population –
Blood-Based Screening Shows Mixed Results for Colorectal Cancer
An investigational, blood-based test for circulating tumor DNA shows “reasonable accuracy” for detecting colorectal cancer (CRC) among people at average risk, researchers report, but its ability to reveal early-stage lesions presents more of a challenge. The clinical validation results of the PREEMPT CRC study, reported in JAMA, suggest further improvements are needed for it to replace traditional colonoscopy and stool-based screening. In an edi…
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