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Clinical Performance of an Automated Stool DNA Assay for Detection of Colorectal Neoplasia

Lidgard, Graham P., Domanico, Michael J., Bruinsma, Janelle J., Light, James, Gagrat, Zubin D., Oldham–Haltom, Rebecca L., Fourrier, Keith D., Allawi, Hatim +7 more·2013·Clinical Gastroenterology and Hepatology
DOI 10.1016/j.cgh.2013.04.023
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Abstract

Background & aims Colorectal cancer (CRC) and advanced precancers can be detected noninvasively by analyses of exfoliated DNA markers and hemoglobin in stool. Practical and cost-effective application of a stool DNA-based (sDNA) test for general CRC screening requires high levels of accuracy and high-capacity throughput. We optimized an automated sDNA assay and evaluated its clinical performance. Methods In a blinded, multicenter, case-control study, we collected stools from 459 asymptomatic patients before screening or surveillance colonoscopies and from 544 referred patients. Cases included CRC (n = 93), advanced adenoma (AA) (n = 84), or sessile serrated adenoma ≥1 cm (SSA) (n = 30); controls included nonadvanced polyps (n = 155) or no colonic lesions (n = 641). Samples were analyzed by using an automated multi-target sDNA assay to measure β-actin (a marker of total human DNA), mutant KRAS, aberrantly methylated BMP3 and NDRG4, and fecal hemoglobin. Data were analyzed by a logistic algorithm to categorize patients as positive or negative for advanced colorectal neoplasia (CRC, advanced adenoma, and/or SSA ≥1 cm). Results At 90% specificity, sDNA analysis identified individuals with CRC with 98% sensitivity. Its sensitivity for stage I cancer was 95%, for stage II cancer it was 100%, for stage III cancer it was 96%, for stage IV cancer it was 100%, and for stages I-III cancers it was 97% (nonsignificant P value). Its sensitivity for advanced precancers (AA and SSA) ≥1 cm was…

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Crossref · 10.1016/j.cgh.2013.04.023

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  • Combining FIT with assay of exfoliated molecular markers in stool expands sensitivity of stool testing for colorectal neoplasia.

    “Combining a FIT application with assay of exfoliated molecular markers in stool has proven to be a rational and effective approach to further expand the sensitivity of stool testing for detection of colorectal neoplasia [8–11].”

    From Novel Approach to Fecal Occult Blood Testing by Assay of Erythrocyte-Specific microRNA Markers (2017) · cites this paper as [10]

  • A multi-target stool test comprising DNA markers and FIT has been approved by FDA for CRC screening, incorporated into guidelines, and become available.

    “A multi-target stool test, comprising a panel of DNA markers and FIT [9–11], has been approved by the Food and Drug Administration (FDA) for CRC screening, been incorporated into CRC screening guidelines by the American Cancer Society and United States Preventive Services Task Force [14, 15], and become available to patients.”

    From Novel Approach to Fecal Occult Blood Testing by Assay of Erythrocyte-Specific microRNA Markers (2017) · cites this paper as [10]

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Authors
Lidgard, G. P., Domanico, M. J., Bruinsma, J. J., Light, J., Gagrat, Z. D., Oldham–Haltom, R. L., Fourrier, K. D., Allawi, H., Yab, T. C., Taylor, W. R., Simonson, J. A., Devens, M., Heigh, R. I., Ahlquist, D. A., & Berger, B. M.
Venue
Clinical Gastroenterology and Hepatology
Publisher
Elsevier BV
Published
2013-10
Volume
11
Issue
10
Pages
1313-1318
ISSN
1542-3565
DOI
10.1016/j.cgh.2013.04.023
Cited by
120
References
0
Language
en
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