Freenome, a biotechnology company pioneering an early cancer detection platform, today announced the publication of detailed results from the pivotal PREEMPT CRC study in JAMA The publication presents findings from the largest prospective study of a blood-based screening test for colorectal cancer (CRC), involving 48,995 average-risk adults aged 45 to 85 who underwent a routine colonoscopy following a blood draw.
Based on data from the 27,010 eligible participants who enrolled consecutively in the study after a predetermined cut-off date, the test met all prespecified primary acceptance criteria. The publication also includes a pre-specified analysis that weighted test performance to match the sex and age distribution of the U.S. population, a method used by the U.S. Food and Drug Administration (FDA) for other CRC screening products.
To pursue its vision of personalized early cancer detection, Freenome developed a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers to detect cancer-specific signals in the bloodstream, including those derived from circulating tumor DNA (ctDNA). The company’s CRC screening blood test was built on this platform and applies an AI/ML-based model to detect specific methylation signatures in ctDNA at a base level. Designed for use with a standard blood draw, the test integrates into routine clinical workflows, leveraging Freenome’s software.
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company is advancing the premarket approval submission for its CRC screening blood test to the FDA, with all modules expected to be completed in mid-2025. Freenome also continues to advance a test versioning strategy focused on assay and algorithm improvements to enhance CRC and APL detection, as well as pursue expansion into additional indications, including lung cancer.
The full manuscript is now available online in JAMA. To access the paper, visit https://jamanetwork.com/journals/jama/article-abstract/2834891.
