At the ACG Annual Scientific Meeting, researchers presented findings on an updated version of Freenome's SimpleScreen CRC blood test evaluated using PREEMPT CRC trial data from 9,001 adults. The updated assay increased detection of advanced precancerous lesions from 13.7% to 18.2% while maintaining 80.4% overall sensitivity for colorectal cancer. Microsimulation modeling indicates the test could reduce colorectal cancer incidence and mortality by 9.5%, leading researchers to plan an FDA approval submission.
Sensitivity performance of updated test
- ▪At a 90% specificity threshold, the updated SimpleScreen CRC test achieved 18.2% sensitivity for advanced precancerous lesions, compared with 13.7% for the original test version.
- ▪The updated SimpleScreen CRC test achieved 80.4% overall sensitivity for colorectal cancer, demonstrating 52% sensitivity for stage I cancer, 100% for stage II, 97.3% for stage III, and 100% for stage IV.
- ▪The updated SimpleScreen CRC test achieved 41.9% sensitivity for high-grade dysplasia lesions, representing an 11.5 percentage point increase over the original test.
Test enhancements and evaluation
- ▪Researchers applied assay and algorithm enhancements to Freenome's blood-based SimpleScreen CRC test to improve sensitivity for advanced precursor lesions and early-stage colorectal cancers.
- ▪Researchers evaluated the updated SimpleScreen CRC test using previously untested blood samples collected before and after the cutoff for the prior validation study in April 2021.
PREEMPT CRC trial cohort
- ▪The 9,001 average-risk adults evaluated in the PREEMPT CRC trial analysis had a mean age of 59.9 years and were 51.3% women and 76.3% white.
- ▪Clinical evaluation of the updated SimpleScreen CRC test analyzed blood samples from 9,001 average-risk adults in the prospective, multicenter PREEMPT CRC trial, including 89 colorectal cancer cases and 1,570 advanced precancerous lesion cases.
Presentation at the ACG meeting
- ▪Dr. Aasma Shaukat presented the updated SimpleScreen CRC microsimulation modeling and trial results at the ACG Annual Scientific Meeting held October 12-14, 2026, in Nashville, Tennessee.
- ▪Dr. Aasma Shaukat stated at the ACG Annual Scientific Meeting that researchers plan to develop future iterations beyond version two of SimpleScreen CRC to further increase sensitivity for advanced lesions.
FDA status and submission plans
- ▪The original version of Freenome's blood-based SimpleScreen CRC screening test is already FDA-approved for colorectal cancer surveillance.
- ▪Dr. Aasma Shaukat and her research team plan to submit the updated SimpleScreen CRC test to the FDA for regulatory approval.
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