Freenome colorectal cancer test data improve on earlier results

An article from Dive Brief Freenome colorectal cancer test data improve on earlier results The new study results could make Abbott, which has an agreement with Freenome to market the blood-based test, the dominant player in colorectal cancer screening, Evercore ISI analysts said. Published July 13, 2026 By Susan Kelly Reporter Share Copy link Email LinkedIn X/Twitter Facebook Print License Add us on Google First published on Dive Brief: Freenome said its updated blood-based colorectal cancer screening test met its primary and secondary endpoints in a pivotal validation study. Called SimpleScreen CRC, the new test showed improvement over an earlier version, particularly in detecting precancerous lesions. Abbott, which inked a collaboration agreement with Freenome last August to bring SimpleScreen CRC to market, will commercialize the test when it gains Food and Drug Administration approval, Freenome said Thursday. The latest study results set up Abbott to be the dominant player in colorectal cancer screening, Evercore ISI analysts said in a note to clients. Dive Insight: Freenome’s screening assay will compete with Guardant Health’s Shield test, which is the first blood test approved by the FDA for primary colorectal cancer screening in average-risk adults age 45 and older. Blood-based tests to screen for colorectal cancer are intended as an option for people who are resistant to taking a stool test or undergoing a colonoscopy procedure. Freenome said blood-based tests have the potential to reach people who might otherwise remain unscreened. Abbott, through its $21 billion acquisition of Exact Sciences, sells the Cologuard stool-based test for colorectal cancer screening. Freenome’s updated test achieved 80.4% sensitivity for detecting colorectal cancer and 18.2% sensitivity for advanced precancerous lesions. The company’s first-generation test demonstrated 79.2% sensitivity for colorectal cancer and 12.5% sensitivity for detecting advanced precancerous lesions. Improvements in sensitivity move the updated SimpleScreen test closer to matching the performance of certain stool-based CRC screening tests, with potentially higher patient adherence, Aasma Shaukat, professor of medicine at New York University Grossman School of Medicine, said in a Freenome statement. Freenome, which submitted a premarket approval application to the FDA in August for the first-generation version of the SimpleScreen CRC test, said it expects that review to be completed in mid-2026. The company intends to submit a supplemental PMA to the FDA for the next-generation SimpleScreen test. Freenome’s commercial collaboration agreement with Abbott included a milestone payment tied to the outcome of the study. The payment will be set at $70 million, pending FDA approval of the next-generation test and a successful transfer of the technology to Abbott, Freenome said. Freenome and Abbott are also collaborating on a multi-year R&D program focused on improving assay performance. Recommended Reading Freenome inks deals to list stock and raise $330M MedTech Dive Freenome posts pivotal liquid biopsy data as FDA filing nears completion MedTech Dive Add us on Google Share Copy link Email LinkedIn X/Twitter Facebook Print License Filed Under: Clinical Trials