Colorectal cancer (CRC) is the second most common cause of cancer-related deaths in the United States. This year, it’s expected that more than 53,000 individuals will die of the disease.1
Although screening for colorectal cancer through colonoscopy or sigmoidoscopy is effective in detecting the disease, nearly 40% of eligible adults do not receive a screening test.2 Blood-based screening tests are being investigated as a potential complementary approach to screening for colorectal cancer that may improve adherence among unscreened individuals.
Results from the large PREEMPT CRC study evaluating the clinical performance of an investigational blood-based colorectal cancer screening test to identify molecular signals of advanced colorectal neoplasia in the average-risk population were reported. The study showed the test accurately detected colorectal cancer risk in adults aged 45 and older who had an average risk of developing the disease.3 The research, conducted by lead study author Aasma Shaukat, MD, MPH, of NYU Grossman School of Medicine, was presented during the 2025 ASCO Gastrointestinal Cancers Symposium.3
Aasma Shaukat, MD, MPH
The PREEMPT CRC study is the largest study underway of any blood-based colorectal cancer screening test, enrolling more than 40,000 individuals at 200 sites across the United States. Between May 2020 and April 2022, the researchers enrolled participants between the ages of 45 and 85 who had an average risk of colorectal cancer. The participants had blood drawn before the bowel preparation for the standard-of-care screening colonoscopy. A total of 27,010 participants had evaluable blood samples and a colonoscopy. Screening colonoscopy and applicable histopathology reports underwent central pathologist review. Blood samples were processed blind to clinical findings.
Primary endpoints included sensitivity for colorectal cancer specificity for advanced colorectal neoplasia (ACN); ACN-negative predictive value; and ACN-positive predictive value. A secondary endpoint was sensitivity for advanced precancerous lesions. The median age of the evaluable participants was 57 years, and 55.8% were women.
After performance was weighted to match U.S. Census data for sex and age distributions, sensitivity for colorectal cancer was 81.1% (95% confidence interval [CI] = 71.3%–88.1%), specificity for those without advanced colorectal neoplasia was 90.4% (95% CI = 90.0%–90.7%), negative predictive value for those without advanced colorectal neoplasia was 90.5% (95% CI = 90.5%–90.7%), and positive predictive value for advanced colorectal neoplasia was 15.5% (95% CI = 13.8%–16.2%). Sensitivity for advanced precancerous lesions was 13.7% (95% CI = 12.4%–15.0%).
“PREEMPT CRC successfully met all primary endpoints, demonstrating acceptable clinical performance of the investigational blood-based test. The U.S. Census sex-age adjusted clinical performance estimates showed improvement in CRC and [advanced precancerous lesions] sensitivity,” concluded the study authors.
DISCLOSURE: The study author’s conflicts of interest can be found at coi.asco.org.
REFERENCES
1. American Cancer Society: Key Statistics for Colorectal Cancer. Available at www.cancer.org. Accessed January 23, 2025.
2. Johns Hopkins Bloomberg School of Public Health: The Rise of Colorectal Cancers Among Younger People. Available at https://publichealth.jhu.edu. Accessed January 23, 2025.
3. Shaukat A, et al: 2025 ASCO Gastrointestinal Cancers Symposium. Abstract 18.
