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. 2023 Aug;21(9):2399-2406.
doi: 10.1016/j.cgh.2022.12.026. Epub 2023 Jan 6.

Multitarget Stool DNA Testing Has High Positive Predictive Value for Colorectal Neoplasia on the Second Round of Testing

Jordan K Voss  1 , Derek W Ebner  2 , Keli N Burger  3 , Douglas W Mahoney  3 , Mary E Devens  2 , Kari L Lowrie  2 , John B Kisiel  4
Affiliations

Multitarget Stool DNA Testing Has High Positive Predictive Value for Colorectal Neoplasia on the Second Round of Testing

Jordan K Voss et al. Clin Gastroenterol Hepatol. 2023 Aug.

Abstract

Background & aims: Multitarget stool DNA (mt-sDNA) testing is a stool-based screening test for colorectal cancer (CRC). In a single instance of testing, the pivotal Food and Drug Administration-approval study (NCT01397747) found that 16% of mt-sDNA tests were positive, and the positive predictive value (PPV) for CRC or advanced precursor lesions (APL) was 27.3%. We aimed to examine real-world longitudinal performance by determining the test-positive rate and PPV of mt-sDNA on the second round of testing.

Methods: Colonoscopy and pathology reports were reviewed retrospectively for patients with a negative mt-sDNA on the first round of screening and a positive mt-sDNA on the second round. The test-positivity rate and PPV for CRC, APL, and any colorectal neoplasia were calculated for the second mt-sDNA and compared with baseline PPVs from a previously published cohort of patients from our institution who tested positive on the first round of screening.

Results: A total of 2758 patients completed a second test at a median of 3.2 years after the first test. Of these, 422 (15%) had a positive second mt-sDNA. The PPV was 0.25% for CRC, 24% for APL, and 67% for any colorectal neoplasia. There was no significant difference in PPV on the second mt-sDNA test compared with the first round (24% vs 28% for APL; P = .12).

Conclusions: mt-sDNA test positive rate and PPV were similar between the first and second rounds of screening. These observations confirm the utility of a second round of mt-sDNA screening and may inform estimates of mt-sDNA effectiveness for CRC screening.

Keywords: Colorectal Neoplasms/Prevention and Control; DNA Methylation; Early Detection of Cancer; Liquid Biopsy.

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Figures

Figure 1.
Figure 1.
Study flow diagram. Mt-sDNA, multitarget stool DNA; CRC, colorectal cancer; APL, advanced precancerous lesion; IDA, iron deficiency anemia; FOBT, fecal occult blood test; IBD, inflammatory bowel disease.
Figure 2.
Figure 2.
Outcomes on the 2nd round of mt-sDNA testing expressed as number of patients out of 100 experiencing the given outcome. 15.3% of patients had a positive test (422/2758). Of the 395 patients with a with a positive test and a diagnostic colonoscopy, 3.8% had CRC or APL (n = 97); 6.4% had non-advanced neoplasia (n = 166), and 5.1% had a negative colonoscopy (n = 132). Mt-sDNA, multitarget stool DNA; CRC, colorectal cancer; APL, advanced precancerous lesion.
Figure 3.
Figure 3.
Positive predictive values of mt-sDNA on the 2nd round testing compared to the 1st round. CRC, colorectal cancer; APL, advanced precursor lesion; CRN, colorectal neoplasia; SSP, sessile serrated polyp. *Eckmann, et al. The American Journal of Gastroenterology. 2020;115(4):608-615
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