Blood-based screening test detects CRC with nearly 80% sensitivity in average-risk adults
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Key takeaways:
- Negative predictive value for nonadvanced colorectal neoplasia was 90.8% and positive predictive value for advanced colorectal neoplasia was 15.5%.
- Sensitivity for advanced adenomas was 12.5%.
WASHINGTON — A blood-based screening test detected colorectal cancer with a sensitivity of 79.2% and a specificity of 91.5% among average-risk adults aged 45 to 85 years, according to research presented at Digestive Disease Week.
“Adherence to colon cancer screening tests is suboptimal with current options of stool-based tests and colonoscopy,” Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman Professor of Medicine at NYU Grossman School of Medicine, told Healio. “Having a blood-based test as an option would enhance our menu of options and may improve adherence to screening.”
The prospective PREEMPT CRC study enrolled 48,995 participants aged 45 to 85 years (mean age, 58.1 years; 55.4% women) at average risk for CRC who underwent standard-of-care screening colonoscopy between May 2020 and April 2022 at more than 200 sites. Researchers collected blood samples from patients before bowel preparation for colonoscopy.
The co-primary endpoints included sensitivity for CRC, specificity for the absence of advanced colorectal neoplasia, negative predictive value for nonadvanced colorectal neoplasia and positive predictive value for advanced colorectal neoplasia. The secondary endpoint was sensitivity for advanced adenomas.
According to results, the clinical validation cohort included 32,731 participants, of whom 82.5% had evaluable blood samples and colonoscopy. All primary endpoints were met.
“The blood-based test was evaluated in a large, diverse U.S. population and has good performance for detection of colorectal cancer,” Shaukat said. “Sensitivity and specificity for colorectal cancer were approximately 80% and 91%, respectively.”
The test also demonstrated a negative predictive value of 90.8% (95% CI, 90.7-90.9) for nonadvanced colorectal neoplasia and a positive predictive value of 15.5% (95% CI, 14.2-16.8) for advanced colorectal neoplasia. Sensitivity for the detection of advanced adenomas was 12.5% (95% CI, 11.3-13.8).
“The test would need FDA, CMS and other regulatory approvals,” Shaukat noted. “Once approved, the test would offer another screening option for colon cancer through a blood draw, which we hope will help boost adherence.”
She continued: “Longer-term studies on effect on CRC incidence and mortality, how often should the test be done and comparative effectiveness studies comparing the test to other modalities are needed.”
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Shaukat A, 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 (hybrid).
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