Off-Label Use of Multitarget Stool DNA Testing in Primary Care

Area of Science:

• Gastroenterology
• Oncology
• Primary Care Medicine

Background:

• Colorectal cancer (CRC) screening is crucial for early detection and prevention.
• Multitarget stool DNA (mt-sDNA) testing is an FDA-approved non-invasive screening tool for CRC.
• Appropriate utilization of CRC screening tests in primary care is essential for effective public health strategies.

Purpose of the Study:

• To evaluate the frequency and patterns of off-label use of multitarget stool DNA (mt-sDNA) testing within a primary care setting.
• To identify factors associated with the off-label utilization of mt-sDNA tests for colorectal cancer screening.

Main Methods:

• A retrospective review of all mt-sDNA orders was conducted over a one-year period (July 1, 2018, to June 30, 2019).
• Patient data were analyzed to determine the proportion of orders meeting criteria for off-label use.
• Statistical analysis, including multivariate analysis, was performed to identify predictors of off-label orders and positive results.

Main Results:

• Out of 902 evaluated patients, 17.7% (160/902) had orders for mt-sDNA testing that met criteria for off-label use.
• Increasing patient age was significantly associated with off-label mt-sDNA orders (OR 2.32 per 10-year increase).
• Multivariate analysis indicated that advanced age (OR 1.04) and the need for diagnostic colonoscopy (OR 2.9) were associated with positive mt-sDNA results.

Conclusions:

• Off-label utilization of mt-sDNA testing is prevalent in primary care settings.
• There is a need for enhanced patient and provider education regarding the appropriate indications for mt-sDNA testing in colorectal cancer screening protocols.