multitarget stool DNA; mt-sDNA, (Cologuard)

^[1]^[2]^[3]^[4]^[5]

Introduction

FDA-approved August 2014

tests patients' stool for
- hemoglobin
- DNA methylation & mutation markers
- total amount of DNA

among average-risk patients testing positive, colonoscopy reveals advanced colorectal neoplasia in 28% (cancer in 1%, advanced polyps in 27%)^[3]
positive predictive value for advanced neoplasia: 23-35%*^[4]; 11%^[5]
negative predictive value 93%^[5]

* lower value for prior negative colonoscopy

* more sensitive but less specific than fecal immunochemical test (FIT)^[4]^[5]

↑ Young K Physician's First Watch, March 27, 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
↑ Medscape Oncology> August 11, 2014 FDA Approves Cologuard for Colorectal Cancer Screening. http://www.medscape.com/viewarticle/829757
↑ ^3.0 ^3.1 Eckmann JD, Ebner DW. Bering J et al. Multitarget stool DNA screening in clinical practice: High positive predictive value for colorectal neoplasia regardless of exposure to previous colonoscopy. Am J Gastroenterol 2020 Apr; 115:608 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32068535 https://journals.lww.com/ajg/FullText/2020/04000/Multitarget_Stool_DNA_Screening_in_Clinical.20.aspx
↑ ^4.0 ^4.1 ^4.2 Voss JK et al. Multitarget stool DNA testing has high positive predictive value for colorectal neoplasia on the second round of testing. Clin Gastroenterol Hepatol 2023 Aug; 21:2399. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36621751 PMCID: PMC10323033 (available on 2024-08-01) https://www.cghjournal.org/article/S1542-3565(23)00004-6/fulltext
↑ ^5.0 ^5.1 ^5.2 ^5.3 Imperiale TF et al. Next-generation multitarget stool DNA test for colorectal cancer screening. N Engl J Med 2024 Mar 14; 390:984. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32439088 Free article. https://www.nejm.org/doi/10.1056/NEJMoa2310336