SimpleScreen CRC blood test met all primary and secondary endpoints in clinical validation, with improved sensitivity for precancerous lesions and colorectal cancer.
Freenome announced results from a clinical validation study for an updated version of its SimpleScreen CRC blood-based colorectal cancer screening test, meeting all primary and secondary endpoints. The study assessed the performance of assay and algorithm improvements, showing increased sensitivity in detecting precancerous lesions compared to the first-generation version.
The updated test demonstrated 18.2% sensitivity for detecting advanced precancerous lesions (APLs) and 41.9% sensitivity for APLs with high-grade dysplasia. For colorectal cancer detection, the test showed 80.4% sensitivity, including 52% of Stage I cases. Specificity for no findings on colonoscopy was 90%, according to the company.
“The sensitivity for APL and APL with HGD for the updated SimpleScreen CRC test is a marked improvement and gets us closer to matching the performance of certain stool-based CRC screening tests, with potentially higher adherence,” says Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study, in a release.
Modeling based on the study results suggests the updated test could result in 7.7% more life-years gained, 9.5% more cases of cancer prevented, and 9.5% more cancer deaths prevented compared to the first-generation version. This translates to 1,582 additional life-years gained and 143 fewer deaths per 100,000 individuals screened.
The clinical validation included samples from participants in the PREEMPT CRC study, a prospective trial that enrolled 48,995 asymptomatic, average-risk adults between the ages of 45 and 85. The trial was conducted at more than 200 sites.
“This study marks a major milestone in our mission to advance blood-based colorectal cancer screening,” says Aaron Elliott, PhD, CEO of Freenome, in a release. “The significant improvement in detecting precancerous lesions demonstrates the critical role our SimpleScreen CRC platform can play in early detection and prevention of colon cancer.”
Freenome submitted a Premarket Approval application to the Food and Drug Administration (FDA) in August 2025 for the first-generation version of the test, with a review expected by mid 2026. The company intends to submit a supplemental application to the FDA for the next-generation version.
Upon regulatory approval, the test will be exclusively commercialized by Abbott. The collaboration includes a $70 million milestone payment tied to the study outcome, pending technology transfer and FDA approval of the updated test.
“These results strengthen our confidence in the role blood-based colorectal cancer screening can play in expanding screening,” says Jake Orville, SVP of Abbott’s cancer diagnostics business, in a release. “Combined with Abbott’s preferred, guideline-supported screening option, we’re uniquely positioned to offer healthcare providers and patients a differentiated colorectal cancer screening portfolio built on innovation, performance, and choice.”
ID 89098145 | Blood Test © Elnur | Dreamstime.com
