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.