Dr Shaukat on the PREEMPT CRC Blood-Based Assay for Average-Risk CRC

"This test adds to the options for blood-based testing for the average-risk population in the US. We think with the addition of [new screening] modalities, we perhaps could boost [colorectal cancer] screening rates in the US population."

Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman Professor of Medicine, Department of Medicine, professor, Department of Population Health, NYU Grossman School of Medicine; director, Outcomes Research, Division of Gastroenterology and Hepatology, codirector, Translational Research Education and Careers, NYU Langone Health, discusses the performance of a blood-based colorectal cancer (CRC) screening test adjusted to the US census age and sex distribution.

The observational study (NCT04369053) evaluated the sensitivity and specificity of the PREEMPT CRC test in an average-risk population and assessed its potential as an alternative screening modality. Shaukat notes that this analysis included 27,010 adults aged 45 years or older without a personal history of cancer, colorectal adenoma, or inflammatory bowel disease, or family history of CRC or hereditary gastrointestinal cancer syndromes. Blood samples were collected before bowel preparation for colonoscopy, and the study end points included sensitivity for CRC and specificity for advanced colorectal neoplasia (ACN), as well as predictive values for ACN.

Findings presented at the 2025 Gastrointestinal Cancers Symposium demonstrated that the test met all primary end points. The observed sensitivity rate for CRC was 79.2% (95% CI, 68.4%-86.9%), with an adjusted sensitivity of 81.1% (95% CI, 71.3%-88.1%). The specificity rate for ACN was 91.5% (95% CI, 91.2%-91.9%), with an adjusted specificity rate of 90.4% (95% CI, 90.0%-90.7%). Sensitivity for ACN was lower, with a positive predictive value of 15.5% (95% CI, 14.2%-16.8%).

Shaukat notes that blood-based screening tests could improve CRC screening accessibility, particularly among populations with low adherence to colonoscopy or stool-based testing. She also highlights that future studies will explore how this modality fits into current screening strategies, with a focus on refining assay performance and determining the optimal screening frequency, cost-effectiveness, and long-term clinical impact of integrating blood-based testing into routine CRC prevention programs.

Shaukat concludes that these results may help expand screening options beyond conventional modalities, potentially facilitating earlier CRC detection and improving population-wide adherence to screening guidelines.