multitarget stool DNA; mt-sDNA, (Cologuard)
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Introduction
FDA-approved August 2014
Indications
- screening for colon cancer
- sensitivity 94% for colorectal cancer, 43% for advanced precancerous lesions
- specificity 93% for colorectal cancer or advanced precancerous lesions
* Cologuard Plus is substantially more sensitive, but slightly less specific, than fecal immunochemical test
Procedure
- tests patients' stool for
- hemoglobin
- DNA methylation & mutation markers
- total amount of DNA
Interpretation
- 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: 23-38%*[4][5]
- negative predictive value 93%[5]
* lower value for prior negative colonoscopy
* more sensitive but less specific than fecal immunochemical test (FIT)[4][5]
More general terms
References
- ↑ 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, Porter K, Zella J et al. Next-generation multitarget stool DNA test for colorectal cancer screening. N Engl J Med 2024 Mar 14; 390:984-993. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38477986 https://www.nejm.org/doi/10.1056/NEJMoa2310336
Kisiel JB, Eckmann JD, Limburg PJ. Multitarget Stool DNA for Average Risk Colorectal Cancer Screening: Major Achievements and Future Directions. Gastrointest Endosc Clin N Am. 2020 Jul;30(3):553-568. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32439088 PMCID: PMC10964930 Free PMC article. Review.