Novel Multitarget Stool RNA Test Shows Promise in Detecting Colorectal Cancer

Results of a phase 3 clinical trial published in JAMA demonstrated that ColoSense, a novel multitarget stool RNA test (mt-sRNA), exhibited strong performance for patients 45 years and older undergoing colorectal cancer screening.

The trial, led by Dr. Erica K. Barnell, of the Washington University School of Medicine, analyzed the sensitivity and specificity of an mt-sRNA test compared with the results of a colonoscopy.

Over 12 months, individuals 45 years and older were enrolled in the trial using a decentralized recruitment strategy based on guidance from the US Food and Drug Administration. The mean age of participants was 55 years.

The blinded, cross-sectional study had all 8920 participants complete the mt-sRNA test. The test included a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status.

Researchers collected stool samples before the participants completed a colonoscopy at their local endoscopy center. They compared the mt-sRNA test results (positive or negative) with index lesions found on colonoscopy.

Of the 8920 patients, 36 (0.4%) had colorectal cancer and 606 (6.8%) had advanced adenomas. The mt-sRNA test sensitivity for detecting colorectal cancer was 94% (95% Cl, 81%-99%), sensitivity for detecting advanced adenomas was 46% (95% Cl, 42%-50%), and specificity for no lesions on colonoscopy was 88%.

Investigators reported that the mt-sRNA test detected lesions with the highest malignant transformation rates at a higher sensitivity relative to those with lower malignant transformation rates (65.2% vs 42.9%, respectively; P=.002).

When compared with FIT, the mt-sRNA test demonstrated high sensitivity for colorectal cancer (94% vs 78%, respectively; P=.01) and advanced adenomas (46% vs 29%, respectively; P=.001).

The mt-sRNA test’s specificity was significantly lower than the FIT’s specificity for no lesions on colonoscopy (95.7% vs 87.9%, respectively; P<.001.)

Researchers observed no serious adverse events.

Investigators determined that the mt-sRNA test could be an effective noninvasive diagnostic for colorectal cancer and advanced adenomas.