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.

Videos

Aasma Shaukat, MD, MPH, discusses the sensitivity of the PREEMPT CRC blood-based assay in detecting colorectal cancer for patients at average risk. 

Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman professor of Medicine and Gastroenterology, Department of Medicine, professor, Department of Population Health, co-director, Translational Research Education and Careers, director, Outcomes Research, Division of Gastroenterology and Hepatology, NYU Grossman School of Medicine, discusses the benefit of diverse enrollment in clinical trials in colorectal cancer (CRC).

The PREEMPT CRC trial (NCT04369053) is a prospective, multi-center, observational trial evaluating a blood-based test for its ability to detect CRC. Samples are collected from average-risk patients receiving a routine screening colonoscopy.

From the outset of the study, the trial design encouraged the inclusion of a diverse representation of the population in terms of geography, age groups, gender, race, and ethnicity, Shaukat says, adding that investigators focused on finding treatment sites that would allow for diverse enrollment across those groups.

Investigators deliberately selected locations that had higher rates of diversity so that results from the trial would be more representative of the real-world population, Shaukat concludes.

Aasma Shaukat, MD, MPH, discusses the benefit of diverse enrollment in clinical trials in colorectal cancer.


Dr. Shaukat on the Benefit of Diverse Enrollment in Clinical Trials in CRC

Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman professor of Medicine and Gastroenterology, Department of Medicine, professor, Department of Population Health, co-director, Translational Research Education and Careers, director, Outcomes Research, Division of Gastroenterology and Hepatology, NYU Grossman School of Medicine, discusses the methods utilized in the PREEMPT CRC trial (NCT04369053) in colorectal cancer (CRC).

PREEMPT CRC is a prospective, multi-center, observational trial evaluating a blood-based test for its ability to detect CRC. Samples are collected from average-risk patients receiving a routine screening colonoscopy.

The study is designed to validate the blood-based test by comparing results against those from a standard colonoscopy, which is still considered the gold standard for screening for CRC, Shaukat says. In addition to being average risk, all patients are at least 45 years old who are scheduled to undergo a screening colonoscopy, Shaukat explains.

The blood test is administered prior to the colonoscopy, and patients provide basic background information as a part of the study, Shaukat continues. The main goal of the study is to evaluate the accuracy of the blood-based test, specifically in its ability to detect advanced adenomas and early CRC, Shaukat concludes.

Aasma Shaukat, MD, MPH, discusses the methods utilized in the PREEMPT CRC trial in colorectal cancer.


Aasma Shaukat, MD

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

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