Freenome reports 18.2% sensitivity for advanced precancerous lesions and 80.4% for colorectal cancer with its updated blood screening test.
An updated version of Freenome’s SimpleScreen CRC blood-based screening test detected advanced precancerous lesions with 18.2% sensitivity, compared with 13.7% reported for the original test in PREEMPT CRC, according to company-announced validation results. Colorectal cancer (CRC) sensitivity was 80.4%, with 90% specificity among participants with no findings on colonoscopy. The results are scheduled for presentation at the American College of Gastroenterology (ACG) 2026 Annual Meeting.¹
For clinicians, the central question is whether improved precancerous lesion detection will translate into greater screening utility. Although sensitivity increased, the updated test still did not detect most advanced precancerous lesions.
“These results suggest that our blood-based screening test may detect precancerous lesions with clinically meaningful sensitivity,” Aaron Elliott, PhD, Freenome’s chief executive officer, said in the announcement.¹ That characterization requires consideration alongside the absolute sensitivity and the pending detailed study results.
Freenome described the investigation as a pivotal clinical validation study evaluating assay and algorithm refinements. The presentation title identifies the population as average risk. Results were adjusted to the age and sex distribution of the US Census to better reflect the intended-use population.¹
Sensitivity for advanced precancerous lesions with high-grade dysplasia increased to 41.9%, compared with 30.5% previously reported. The company also reported improved sensitivity across villous or tubulovillous lesions, adenomas measuring at least 10 mm, sessile serrated lesions or polyps measuring at least 10 mm, and traditional serrated adenomas. Subtype-specific estimates were not included in the announcement.¹
Freenome characterized the overall advanced precancerous lesion improvement as significant, but did not provide confidence intervals, statistical testing details, sample size, or participant characteristics. The earlier PREEMPT CRC validation study was published in JAMA in 2025 and serves as the historical comparator cited in the announcement.¹,² The comparison should not be interpreted as a randomized, head-to-head assessment of the 2 versions.
The update concerns a screening test rather than a treatment. Freenome frames precancerous lesion detection as important for potential CRC prevention and positions blood-based screening as an option for people who remain unscreened. However, the announced validation findings address test performance, not screening uptake, cancer incidence, or mortality.¹
According to Freenome, the FDA approved the first-generation SimpleScreen CRC test in July 2026, and Abbott Cancer Diagnostics launched it commercially in the United States in late September. The announcement does not report FDA approval of the updated version.¹ Clinicians should therefore distinguish the marketed test’s regulatory status from the investigational performance update.
Freenome’s discovery platform analyzes circulating cell-free DNA methylation patterns alongside additional biomarkers. The company attributes the updated test’s performance to assay and algorithm refinements, although it does not specify which changes contributed to the reported gains.¹
The company reported that overall CRC detection remained consistent with the first version. Detailed results will be needed to assess stage-specific cancer sensitivity, uncertainty around the estimates, and performance across demographic groups. The announcement also provides no safety outcomes or assessment of downstream procedures.¹
Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a PREEMPT CRC co-lead investigator, is scheduled to present the findings October 14 in Nashville.¹ The presentation should help clarify the study’s methods and the clinical significance of the increased lesion sensitivity.
