Blood-Based Test May be Effective Option for Colorectal Cancer Screening in Average-Risk Adults

The PREEMPT-CRC study, the largest prospective study of a blood-based test for colorectal cancer (CRC) screening, successfully met all primary endpoints among a cohort of average-risk adults aged 45 to 85 years.¹

The investigational blood-based screening test demonstrated a 79.2% sensitivity for detecting CRC and a 91.5% specificity for identifying the absence of advanced colorectal neoplasia (non-ACN), according to the results presented during Digestive Disease Week 2024, May 18-21, 2024, in Washington, DC.¹

“The study suggests that this blood test could offer a convenient and effective screening option for colorectal cancer in the average-risk population, potentially helping to address underutilization of screening methods,” presenting author Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman professor of medicine, director of outcomes research, division of gastroenterology and hepatology, New York University Grossman School of Medicine, said in a press release.²

Despite CRC screening being widely recommended, it is significantly underutilized in the US. According to Shaukat and colleagues, nearly 40% of eligible adults in the US are not up to date with CRC screening.¹

“The recent lowering of screening age to 45 has expanded the screen eligible population by 20%,” researchers explained. “Studies show a preference for blood-based options among previously unscreened individuals, suggesting that introducing blood-based testing alongside conventional methods may increase screening rates.”¹

To examine the clinical performance of a blood-based screening test in average-risk individuals, investigators enrolled 48 995 participants aged 45 to 85 years at average risk for CRC who underwent standard-of-care screening colonoscopy (CS) between May 2020 and April 2022 at more than 200 sites mainly in the US. They collected blood samples from patients before bowel preparation for CS.¹

The coprimary endpoints included sensitivity for CRC, specificity for non-ACN, negative predictive value (NPV) for non-ACN, and positive predictive value (PPV) for ACN. The secondary endpoint was sensitivity for advanced adenomas (AA). The acceptance criteria had to be met for all primary endpoints for study success, researchers noted.¹

Among the 48 995 participants enrolled, 32 731 were sequentially enrolled and included in the clinical validation (CV) cohort, of whom 82.5% (n=27 010) had evaluable blood samples and CS. The majority (71.5%) of the CV cohort were White, 8.2% were Asian, 11.9% were Black, and 12.6% were Hispanic or Latino. Mean age was 58.1 years and 55.4% of the cohort were women.¹

Researchers reported that the study met all primary endpoints¹:

• Sensitivity for CRC detection: 79.2%
• Specificity for non-ACN: 91.5%
• NPV for non-ACN: 90.8%
• PPV for ACN: 15.5%
• Sensitivity for detection of AA: 12.5%

“These results underscore the potential of blood-based screening in colorectal cancer screening, providing a noninvasive option that could impact public health,” Shaukat said in the press release.²

References:

1. Shaukat A, Meng Z, Sun CK, et al. Clinical evaluation of a blood-based screening test for the early detection of colorectal cancer. Presented at: Digestive Disease Week; May 18-21, 2024; Washington DC.
2. NYU Langone Gastroenterologists present clinical findings & research at Digestive Disease Week 2024. News release. NYU Langone. May 20, 2024. Accessed May 22, 2024. https://nyulangone.org/news/nyu-langone-gastroenterologists-present-clinical-findings-research-digestive-disease-week-2024