Clinical Validation of a Simplified, Scrape-Free Collection Method for Multitarget Stool RNA Testing in Colorectal...

Area of Science:

• Gastroenterology
• Oncology
• Clinical Diagnostics

Background:

• Most colorectal cancer (CRC) screening tests, such as fecal immunochemical tests (FIT) and multitarget stool DNA tests, require at-home stool sample collection, which can reduce adherence and introduce errors.
• The multitarget stool RNA (mt-sRNA) test is an FDA-approved stool-based screening tool for CRC and advanced adenomas (AA) that uniquely processes the FIT component in a laboratory setting, avoiding at-home sample handling by patients.

Purpose of the Study:

• To evaluate the comparability of at-home versus in-laboratory FIT methods.
• To assess how these FIT methods impact the performance of the mt-sRNA test for detecting colorectal neoplasia.

Main Methods:

• A comparative analysis was conducted using banked residual stool samples from the CRC-PREVENT clinical trial.
• Both at-home and in-laboratory FIT methods were applied to 1079 samples, and results were compared against each other and colonoscopy findings for concordance, sensitivity, and specificity.

Main Results:

• Overall concordance between at-home and in-laboratory FIT was 93%.
• Sensitivity for CRC was 75% for both methods. For advanced adenomas (AA), sensitivities were 33% (at-home) and 38% (in-laboratory).
• When the in-laboratory FIT was integrated into the mt-sRNA test, method-calibrated sensitivities improved to 94% for CRC and 48% for AA, with 90% specificity.

Conclusions:

• In-laboratory FIT demonstrates potential to enhance the diagnostic accuracy of the mt-sRNA test.
• This approach may also mitigate issues related to inadequate sampling and improve the overall patient experience.