On October 11, 2026 Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company developing blood-based tests, reported the company will present late-breaking data on an updated version of its SimpleScreen CRC blood-based screening test at the American College of Gastroenterology (ACG) 2026 Annual Meeting in Nashville.

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Freenome conducted a pivotal clinical validation study to assess the performance of assay and algorithm improvements for the updated version of SimpleScreen CRC. The FDA approved the first-generation version of SimpleScreen CRC in July 2026, and the test was commercially launched in late September in the United States by Freenome’s partner Abbott Cancer Diagnostics.

The updated test demonstrated 18.2% sensitivity for detecting advanced precancerous lesions (APLs), a significant improvement compared to the 13.7% sensitivity in the original PREEMPT CRC study.1 Sensitivity for APLs with high-grade dysplasia (HGD) improved to 41.9% in the updated test, compared to 30.5% reported previously. The sensitivity results for APLs and APLs with HGD demonstrated in this study are the highest reported to date for any non-invasive screening blood test in a prospective registrational pivotal clinical study.

Sensitivity was also improved for all APL subtypes, including villous or tubulovillous; adenomas ≥ 10 mm; sessile serrated lesions/polyps ≥ 10 mm; and traditional serrated adenomas.

Overall, 80.4% sensitivity was demonstrated for detecting CRC. The results were adjusted to the age and sex distribution of the U.S. Census to better reflect the intended use population, and specificity for no findings on colonoscopy was 90%.

"These results suggest that our blood-based screening test may detect precancerous lesions with clinically meaningful sensitivity," said Aaron Elliott, Ph.D., CEO of Freenome. "The ability to continually improve performance through refinements to our assay and algorithm, as seen with these results, is a fundamental part of our up-versioning strategy. We believe this iterative methodology not only improves CRC APL performance but is also applicable across our multi-cancer pipeline. Combined with our personalized cancer detection approach, this is how we continue to expand blood-based screening into an accessible option for the millions of Americans who remain unscreened."

Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study, will present the detailed results.

Presentation title: Improved Sensitivity for Advanced Precancerous Lesions (APLs) Demonstrated in Clinical Validation of an Updated Colorectal Cancer (CRC) Screening Blood Test in an Average-Risk Population.

Date: Wednesday, Oct. 14
Time: 9:10-9:20 am
Session: Plenary Session 4B: Liver, Esophagus, CRC, IBD

(Press release, Freenome, OCT 11, 2026, View Source [SID1234673319])