A multitarget stool DNA test for colorectal cancer (CRC; Cologuard®) was found to have high specificity in a group of average-risk 45- to 49-year-olds, thereby supporting its use as a noninvasive screening option, according to the results of a recent study.1

Cologuard, which detects biomarkers associated with advanced colorectal neoplasia, is currently recommended by the American Cancer Society and the United States Preventive Services Task Force and was first approved in 2014 for CRC screening in average-risk individuals aged 50 years and older.

This study was designed to test the multitarget stool DNA test in 816 patients aged 45 years to 49 years (median age, 47.8 years) who were considered to be at average risk for CRC. Specificity was the primary outcome.

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“For a screening test to be viable in a low prevalence setting, it requires high specificity to minimize the costs and burdens resulting from false-positive test results,” the researchers explained.

No patients had CRC. The study population included individuals with advanced precancerous lesions (APL; 49 patients), nonadvanced adenomas (NAA; 253 patients), and a subgroup of participants with negative colonoscopy findings (514 patients).

The test had a specificity of 95.2% among participants with NAA or negative colonoscopy findings, which was higher than that in participants aged 50 years or older, the researchers wrote. The specificity did not differ by participant sex or race in these 2 groups.

Sensitivity for APL was 32.7%, with the test detecting 16 of 49 APL. The majority of APL (83.7%) measured 10 mm to 19 mm. None were high-grade dysplasia. The area under the ROC curve for discrimination between APL and lesser findings was 0.72.

No adverse events occurred among the study participants.

“Using noninvasive screening in this age group would identify individuals most likely to benefit from colonoscopy, thereby mitigating the impact of potential diversion of colonoscopy resources from higher risk patients to screening younger individuals with lower risks of colorectal cancer and APL (as evidenced by the current data showing no

colorectal cancers and low prevalence of APL in this study population), as the latter are less likely to benefit from colonoscopy,” the study authors concluded.

Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study. This study was supported by Exact Sciences.


Imperiale TF, Kisiel JB, Itzkowitz SH, et al. Specificity of the multi-target stool DNA test for colorectal cancer screening in average-risk 45-49 year-olds: a cross-sectional study. Cancer Prev Res (Phila). Published online January 12, 2021. doi:10.1158/6207.CAPR-20-0294