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Off-Label Use of Multitarget Stool DNA Test Is Common in Primary Care

Douglas K. Rex, MD, MASGE, reviewing Agarwal A, et al. Am J Gastroenterol 2021 Jan 25.

In a retrospective analysis of all multitarget stool DNA (mt-sDNA) tests ordered at a single center over one year by 62 primary care providers (50 physicians and 12 nurse practitioners), mt-sDNA was ordered for 902 patients. About 27% of patients never returned the sample or had an indeterminate result and did not resubmit a test. Of completed tests, the positivity rate was 18.9%, but 23% of patients with positive results did not complete diagnostic colonoscopy, although the provider recommended it in 97% of cases.

Of all 902 orders, 17.7% were for off-label indications. Increasing age was associated with higher odds of an off-label order (odds ratio, 2.32 for each 10-year age increase). A positive test result was associated with older age and having a baseline indication for diagnostic colonoscopy. The latter was associated with a 3-fold increased chance of a positive result. Among the practitioners, ordering tests for off-label indications ranged from 0% to 71%.

Douglas K. Rex, MD, FASGE


These results from a single center indicate that off-label ordering, failure to return the test, failure to undergo colonoscopy after a positive test, inappropriate bias toward the use of mt-sDNA tests in elderly persons, and overall high rates of positivity are all significant clinical problems with mt-sDNA testing.

Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.


Agarwal A, Zhang T, Ravindran N, Thuluvath PJ, Maheshwari A. Off-label use of multitarget stool DNA testing in primary care. Am J Gastroenterol 2021 Jan 25. (Epub ahead of print) (

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