Freenome's updated SimpleScreen CRC test improves APL sensitivity
Freenome will present late-breaking validation data at the American College of Gastroenterology (ACG) 2026 Annual Meeting in Nashville this week, showing that an updated version of its SimpleScreen CRC blood-based screening test delivers meaningfully higher sensitivity for advanced precancerous lesions (APLs) than its predecessor.
The pivotal clinical validation study found that the updated assay and algorithm combination achieved 18.2% sensitivity for APL detection, up from 13.7% in the original PREEMPT CRC registrational study published in JAMA in June 2025. Sensitivity for APLs with high-grade dysplasia improved to 41.9%, compared with 30.5% previously. The company says both figures are the highest yet reported for any prospective, non-invasive CRC screening blood test in a registrational pivotal study. Overall colorectal cancer detection held steady at 80.4% sensitivity at 90% specificity, results adjusted to match US Census age and sex distributions.
The improvements spanned all APL subtypes evaluated, including villous or tubulovillous adenomas, adenomas of 10 mm or greater, sessile serrated lesions and polyps of 10 mm or greater, and traditional serrated adenomas.
Clinical and commercial context
FDA cleared the first-generation SimpleScreen CRC in July 2026, and Abbott Cancer Diagnostics, Freenome's commercial partner, launched the test in the United States in late September. The validation data being presented at ACG reflect an already-planned successor iteration rather than a post-approval problem, positioning Freenome to pursue a label update or supplemental submission for the improved version.
Aaron Elliott, chief executive of Freenome, said the results "suggest that our blood-based screening test may detect precancerous lesions with clinically meaningful sensitivity," and framed the iterative assay-and-algorithm refinement process as integral to a broader pipeline strategy spanning lung cancer and additional indications. The detailed results will be delivered by Aasma Shaukat, professor of medicine at NYU Grossman School of Medicine and co-lead principal investigator on the PREEMPT CRC study, in a plenary session on 14 October.
Market landscape
Blood-based CRC screening is a rapidly evolving and competitive field. Exact Sciences' Cologuard remains the dominant stool-based molecular test, while Guardant Health's Shield blood test received FDA approval in 2024 and has been recommended by the American Cancer Society as a primary screening option, adding pressure on newer entrants to differentiate on both performance and access. Freenome's emphasis on iterative algorithm improvement, rather than a static approved product, is a notable strategic posture: it positions the company to keep pace with improving liquid-biopsy science without requiring a full re-registration cycle each time.
The APL sensitivity gap remains a sector-wide challenge. No currently approved blood-based test approaches the sensitivity of colonoscopy for precancerous lesion detection, which remains the procedural gold standard. Clinicians will scrutinise whether a step-change from 13.7% to 18.2% APL sensitivity is sufficient to influence screening guidelines, particularly given the American Cancer Society's evolving position on blood-based alternatives. Regulatory and health-technology assessment bodies will also be watching how iterative improvements interact with existing approved labelling, a question that has no firmly established precedent in this indication.
With SimpleScreen commercially live through Abbott's distribution network, Freenome's near-term milestones include Medicare reimbursement decisions and potential guideline inclusion by gastroenterology societies, both of which would materially affect uptake among the large population of Americans who currently forego any CRC screening.