Study Introduces Novel RNA-Based Test for Colorectal Cancer Screening

Colorectal cancer claims the lives of over 52,000 Americans each year, making it the second leading cause of cancer-related mortality in the United States. Despite the need to increase colorectal cancer screening for those aged 45 to 49, adherence to the recommended colonoscopy has plateaued at roughly 60% as a result of recent guideline modifications. 

The ColoSense test is a novel multitarget stool RNA (mt-sRNA) test that was utilized to identify colorectal cancer and advanced adenomas in a prospective pivotal trial with 8,920 patients. This RNA-based technique has the potential to be more sensitive than standard imaging and endoscopy in diagnosing colorectal malignancy. 

According to the study findings, the mt-sRNA test had a 46% sensitivity for advanced adenomas and a 94% sensitivity for colorectal cancer in people aged 45 and up. It is worth noting that the test revealed 100% sensitivity for colorectal cancer and 45% sensitivity for advanced adenomas in the newly defined age range of 45-49 years. 

This research is the first step toward clinically validating a distributed platform for colorectal cancer screening. By using unique techniques to recruit people who were not currently participating in screening, we achieved considerably greater participation rates than previously available noninvasive testing platforms. 

The alarming rise in the frequency of colorectal cancer in younger people makes the findings of this study all the more critical. Colorectal adenomas were discovered in 35% of persons aged 45 to 49, with a 0.24% chance of developing colorectal cancer. There has been a considerable knowledge vacuum about the effectiveness of noninvasive screening tests in younger groups, which this article fills. 

The mt-sRNA test shows excellent sensitivity in individuals aged 45-49. It is a valuable tool for boosting adherence and identifying persons at higher risk of developing colorectal cancer and advanced adenomas. In this work, we show that RNA biomarkers resistant to age-related methylation patterns have the potential to improve test reliability across age groups. 

The rate at which adenomas are found is an essential metric for gastroenterologists. This study discovered a 40% adenoma detection rate overall; however, among patients with a positive mt-sRNA test result, that number increased to 54%. This test has the potential to improve clinical outcomes by increasing the number of individuals who get colonoscopies due to its increased sensitivity for advanced adenomas. 

For those aged 50 and up, the sensitivity of the mt-sRNA test for detecting colorectal cancer and advanced adenomas was equivalent to that of the mt-sDNA test. However, the sensitivity of the mt-sRNA test was much higher among those under the age of 50. Although the mt-sRNA test has lower specificity than FIT, the study’s authors argue that it is a feasible alternative to annual FITs since it allows for a three-year screening interval. 

As research into noninvasive colorectal cancer screening advances, the mt-sRNA test appears to be a promising paradigm shift in the approach to early diagnosis and prevention of colorectal cancer. If further study is conducted and the FDA approves it for use in colorectal cancer screening, it may save lives and improve health outcomes.

Journal Reference  

Erica K. Barnell, M. (2023). Multitarget Stool RNA Test for Colorectal Cancer Screening. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2811133