دورية أكاديمية
Analytical Validation of the Multitarget Stool RNA Test for Colorectal Cancer Screening.
| العنوان: | Analytical Validation of the Multitarget Stool RNA Test for Colorectal Cancer Screening. |
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| المؤلفون: | Barnell EK; Department of Medicine, Washington University School of Medicine, St. Louis, Missouri; Geneoscopy Inc., St. Louis, Missouri. Electronic address: e.barnell@wustl.edu., Land J; Geneoscopy Inc., St. Louis, Missouri., Kruse K; Geneoscopy Inc., St. Louis, Missouri., Scott MC; Geneoscopy Inc., St. Louis, Missouri., Wedeking B; Geneoscopy Inc., St. Louis, Missouri., Morrison C; Geneoscopy Inc., St. Louis, Missouri., Grass C; Geneoscopy Inc., St. Louis, Missouri., Zuniga A; Geneoscopy Inc., St. Louis, Missouri., Wurtzler EM; Geneoscopy Inc., St. Louis, Missouri., Duncavage EJ; Department of Pathology and Immunology, Washington University, St. Louis, Missouri. |
| المصدر: | The Journal of molecular diagnostics : JMD [J Mol Diagn] 2024 Aug; Vol. 26 (8), pp. 700-707. Date of Electronic Publication: 2024 Jul 10. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 100893612 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1943-7811 (Electronic) Linking ISSN: 15251578 NLM ISO Abbreviation: J Mol Diagn Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2011- : New York : Elsevier Original Publication: Bethesda, MD : American Society for Investigative Pathology and the Association for Molecular Pathology, 1999- |
| مستخلص: | The multitarget stool RNA (mt-sRNA) test (ColoSense) is a noninvasive diagnostic test that screens for colorectal cancer and advanced adenomas in average-risk individuals aged 45 years and older. The mt-sRNA test incorporates a commercially available fecal immunochemical test, concentration of eight RNA transcripts, and participant-reported smoking status. As part of the CRC-PREVENT (Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test) clinical trial, 12 analytical validation studies were conducted to assess analytical sensitivity, linearity, precision, interfering substances, cross-reactivity, carry-over, cross-contamination, and robustness. Analytical validation of the mt-sRNA test demonstrated limit of blank, limit of detection, and limit of quantification of <0.6, <0.7, and ≤2.5 copies/μL for all markers, respectively. The mt-sRNA test demonstrated linearity between 2.5 and 2500 copies/μL, and <20% coefficient of variation, and/or ≥95% concordance with regard to precision, interfering substances, carry-over, cross-contamination, and robustness. There was no significant impact of cross-reactivity from non-colorectal cancer diseases. These data provide a framework for laboratories to complete analytical validation for RNA-based panels that require premarket approval as a class III medical device from the US Food and Drug Administration. Competing Interests: Disclosure Statement E.J.D. is a paid consultant for Geneoscopy Inc. E.K.B. is an owner, employee, and member of Geneoscopy Inc. E.K.B. and E.M.W. are inventors of the intellectual property owned by Geneoscopy Inc. J.L., K.K., M.C.S., B.W., C.M., C.G., A.Z., and E.M.W. are employees and owners of Geneoscopy Inc. All individuals in the Acknowledgements were compensated by Geneoscopy Inc. as part of their efforts in completing the Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test (CRC-PREVENT) clinical trial. (Copyright © 2024 Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.) |
| تواريخ الأحداث: | Date Created: 20240713 Latest Revision: 20240727 |
| رمز التحديث: | 20240727 |
| DOI: | 10.1016/j.jmoldx.2024.05.001 |
| PMID: | 39001727 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1943-7811 |
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| DOI: | 10.1016/j.jmoldx.2024.05.001 |