THE COLOGUARD TEST VS FIT

Cologuard® is the best-in-class noninvasive screening option in detecting colorectal cancer (CRC) and precancer vs FIT1-4*

  • Cologuard Plus™
  • Cologuard

The Cologuard Plus test has superior sensitivity vs FIT1*

Based on a subset of 18,911 average-risk patients aged 45-84 years from a prospective, multicenter study.1†:

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FIT failed to detect 6 times more total CRC findings (stage I to IV)1

Horizontal bar chart comparing the specificity of the Cologuard Plus® test vs FIT at different stages of colorectal cancer.

91% specificity with the Cologuard Plus test‡ vs 95% with FIT.1

  • The Cologuard Plus test detected ~2x more advanced precancerous lesions than FIT1§
  • The Cologuard Plus test detected ~10x more sessile serrated lesions than FIT1||

The Cologuard Plus test more effectively detects precancer vs FIT1*

Cologuard box.

Better outcomes with the Cologuard Plus test

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Choose the best-in-class noninvasive CRC screening option, the Cologuard Plus test1,2

Proprietary Cologuard Plus sDNA technology analyzes and detects 5 distinct biomarkers to identify CRC and precancerous polyps.1

Icon Cologuard box with checkmark

The Cologuard Plus test1,2


Detects 5 biomarkers


Detects methylated DNA markers and hemoglobin


Optimized molecular panel


Consistent detection of both left- and right-sided cancers

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FIT3,5


Detects 1 biomarker

 

Only detects hemoglobin in stool


Detects hemoglobin from polyps or lesions that bleed intermittently


Less effective detection of proximal cancers

The Cologuard test demonstrated superior sensitivity vs FIT* in detecting CRC and advanced precancerous polyps3,4

In a 2014, prospective, head-to-head, point-in-time, 90-site, pivotal study of 10,000 patients aged 50 to 84 years at average risk for CRC, the Cologuard test demonstrated3†:

FIT failed to detect 3 times more total CRC findings (stage I to IV)3

Horizontal bar chart comparing the specificity of the Cologuard® test vs FIT at different stages of colorectal cancer.

87% specificity with the Cologuard test vs 95% with FIT.3

  • The Cologuard test detected ~2x more advanced precancerous lesions than FIT4#
  • The Cologuard test detected ~9x more sessile serrated lesions than FIT4**

The Cologuard test detects precancer more effectively vs FIT4*

Cologuard box.

Better outcomes with the Cologuard test

Explore more data comparing noninvasive options.

View Data

Higher sensitivity makes the Cologuard test the superior CRC screening option vs FIT3,4

The proprietary Cologuard sDNA technology can analyze and detect 11 distinct biomarkers that are used to identify CRC and precancerous polyps.3,4

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The Cologuard test3,4


Detects 11 biomarkers


Detects altered DNA and hemoglobin


Detects biomarkers that are continuously shed into the stool


Consistent detection of both left- and right-sided cancers

Icon blood drop with plus sign inside
FIT3,5


Detects 1 biomarker

 

Only detects hemoglobin in stool


Detects hemoglobin from polyps or lesions that bleed intermittently


Less effective detection of proximal cancers

FIT only detects hemoglobin in stool, increasing the chance of a false negative result due to intermittent bleeding.3,5

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Ease of use

Explore how the Cologuard test may help address potential barriers to CRC screening

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  • * OC-Auto® Micro 80, Polymedco, Inc. was the comparator to the Cologuard Plus test. OC FIT-CHEK, Polymedco, Inc was the comparator to the Cologuard test.
  • † Screening colonoscopy was the reference method.1,3
  • ‡ Cologuard Plus specificity: 91% overall specificity, including all participants who did not have advanced neoplasia. Specificity for no colorectal neoplasia was age-weighted to the US population and defined as a negative colonoscopy, no adenocarcinoma of the colorectum, no adenomas, and no sessile serrated polyps/sessile serrated adenomas.1
  • § The Cologuard Plus test detected 43% of advanced precancerous lesions vs 23.3% with FIT (P<0.0001).1
  • || The Cologuard Plus test detected 49% of sessile serrated lesions with dysplasia, traditional serrated adenomas, conventional adenomas with serrated architecture, and sessile serrated lesions ≥10 mm vs 5% with FIT.1
  • ¶ Cologuard specificity: 87% overall specificity, excluding CRC and advanced adenomas, and including all nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy. There was 90% specificity in participants with no lesions biopsied on colonoscopy.3
  • #The Cologuard test detected 42% of advanced adenomas compared to 24% with FIT (P<0.001).4
  • **The Cologuard test detected 43% of sessile serrated lesions ≥10 mm vs 5% with FIT (P<0.001).4

FIT=fecal immunochemical test; sDNA=stool DNA.