Search
multitarget stool DNA; mt-sDNA, (Cologuard)
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]
General
hemoglobin in stool
fecal DNA testing
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
- 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: 32068535
https://journals.lww.com/ajg/FullText/2020/04000/Multitarget_Stool_DNA_Screening_in_Clinical.20.aspx
- 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: 36621751 PMCID: PMC10323033 (available on 2024-08-01)
https://www.cghjournal.org/article/S1542-3565(23)00004-6/fulltext
- 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: 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: 32439088 PMCID: PMC10964930 Free PMC article. Review.