A recent study conducted by Dr. Aasma Shaukat, MD, MPH, from New York University Grossman School of Medicine, has demonstrated the effectiveness of a blood-based test for the early detection of colorectal cancer (CRC). The study, known as PREEMPT CRC, met its prespecified sensitivity and specificity endpoints, showcasing promising results for the future of CRC screening.
The blood-based test showed a sensitivity for CRC of 79.2% and a specificity for non-advanced colorectal neoplasia of 91.5% when using genomics testing. Additionally, multiomics testing exhibited a sensitivity of 77.8% and a specificity of 93.7%. The negative predictive value for non-advanced colorectal neoplasia was found to be 90.8%, while the positive predictive value ranged from 15.5% to 17.7% with different testing methods. Moreover, the sensitivity for advanced adenoma was 12.5% with genomics testing and 29.1% for high-grade dysplasia or carcinoma in situ.
Development of the Blood-Based Test
The blood-based test was developed using case-control samples of patients with CRC and advanced adenomas. The testing platforms included genomics, multiomics, and proteomics. The data collected were utilized in a machine-learning and artificial intelligence algorithm to create a signature of advanced CRC. The study featured two classifiers based on genomic and multiomics platforms, both yielding similar results. Dr. Shaukat emphasized the importance of a more widely accepted CRC screening program, highlighting the shortcomings of current screening methods.
Addressing the Need for Improved Screening
Dr. Phillip Ge, a session moderator from the University of Texas MD Anderson Cancer Center, emphasized the significance of innovative screening alternatives. He emphasized the challenges associated with convincing individuals to undergo colonoscopy, the current gold standard for CRC screening. Dr. Ge acknowledged the resistance and access issues surrounding colonoscopy, underscoring the potential for blood-based and stool-based systems to bridge the gap in CRC screening.
The study included 27,010 participants aged 45-85 from various centers across the United States. Participants had no personal history of CRC, colorectal adenoma, or inflammatory bowel disease, among other criteria. The results demonstrated varying levels of sensitivity based on the stage of CRC, with promising results for stages II and IV.
Future Directions and Research
While the blood-based test exhibited promising results in the PREEMPT CRC study, Dr. Shaukat highlighted the need for further research to refine the algorithm and improve the test’s accuracy. The study was not designed to evaluate the impact of the test on CRC incidence or mortality, nor to compare the effectiveness of different screening methods. Dr. Shaukat’s research team is currently focused on enhancing the algorithm to enhance the test’s diagnostic capabilities.
The blood-based test showcased in the PREEMPT CRC study represents a significant advancement in the early detection of colorectal cancer. While further research is needed to optimize the test and assess its long-term impact, these findings offer hope for a more effective and accessible CRC screening method for individuals worldwide.
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