The Cologuard Plus® Test: FDA-approved next-generation stool DNA test

Colorectal cancer screening

The Cologuard Plus test is intended for the qualitative detection of colorectal neoplasia-associated DNA markers and the presence of occult hemoglobin in human stool. It is indicated to screen adults aged 45 years or older who are at average risk for colorectal cancer (CRC).

Evaluated in a large prospective study

The Cologuard Plus test was studied in a prospective, cross-sectional trial that assessed its performance characteristics compared with fecal immunochemical testing (FIT) for the detection of CRC. More than 26,000 participants were enrolled, with 18,911 included in the primary analysis. The mean participant age was 63.0 years. The Cologuard Plus test and FIT were performed on each stool sample, followed by screening colonoscopy.

Sensitivity for CRC and advanced precancerous lesions

The Cologuard Plus test had significantly higher sensitivity than FIT for all screening-relevant lesions; sensitivity did not vary significantly according to cancer stage.

For overall CRC, the Cologuard Plus test demonstrated 95.3% sensitivity (81/85), compared with 70.6% (60/85) for FIT (P<0.0001). Out of 100 people with CRC, the Cologuard Plus test would correctly identify approximately 95 people, compared with approximately 71 with FIT.

For advanced precancerous lesions (APLs), the Cologuard Plus test demonstrated 43.3% sensitivity (849/1,962), compared with 23.3% (457/1,962) for FIT (P<0.0001). Out of 100 people with APLs, the Cologuard Plus test would correctly identify approximately 43 people, compared with approximately 23 with FIT.

Specificity

The Cologuard Plus test and FIT were both highly specific for the detection of CRC and APLs.

Among participants in Categories 3–6 (no CRC or APLs), the Cologuard Plus test demonstrated 90.7% specificity (15,297/16,864), compared with 94.8% (15,987/16,864) for FIT. Out of 100 people without CRC or advanced colorectal precancer, the Cologuard Plus test would incorrectly identify approximately 9 people, compared with approximately 5 with FIT.

Among participants in Category 6 (no colorectal neoplastic findings), the Cologuard Plus test demonstrated 93.8% specificity.

Following a positive result

A positive Cologuard Plus test may indicate the presence of CRC or APLs and should be followed by a colonoscopy.

References 

Full citations supporting the clinical and scientific information presented above are included in the downloadable infographic.