Significantly improved sensitivity over a leading fecal immunochemical test (FIT)* for detecting colorectal cancer and precancer^1,2

Sensitivity	Cologuard	Fit (OC FIT-CHEK, Polymedco, Inc.)
All CRC (stages I to IV)^†‡	92%	74%
CRC stages I to II^1,3†‡	94%	70%
Advanced precancer¹	42%	24%
High-grade dysplasia¹	69%	46%
Sessile serrated polyp ≥ 1cm¹	42%	5%
Proximal cancer¹⁴	90%	67%
≥3 cm precancer¹²	68%	42%

• 87% specificity overall with Cologuard^1§ vs 95% with FIT¹

Study design: Results from a prospective, head-to-head, point-in-time, 90-site, pivotal study of 10,000 patients aged 50-84 years at average risk for CRC, published in The New England Journal of Medicine. In the pivotal study, screening colonoscopy was the reference method.¹ Cologuard performance in patients aged 45 to 49 years was estimated by sub-group analysis of near-age groups.

The science behind Cologuard

Based on breakthrough stool DNA (sDNA) technology^1,2

The proprietary sDNA technology of Cologuard can analyze and detect 11 distinct biomarkers that identify colorectal cancer and precancer.

Cologuard

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

FIT*

Detects 1 biomarker
Only detects hemoglobin in stool
Detects hemoglobin from polyps or lesions that bleed intermittently
Does not detect right-sided cancers as well as left-sided

Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn's disease; or have a family history of colorectal cancer, or certain hereditary syndromes.

See how easy CRC screening can be

IBD=inflammatory bowel disease

^*OC FIT-CHEK, Polymedco, Inc.

^†Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); Ill: 90% (n=10); IV: 75% (n=4).¹

^‡OC FIT-CHEK sensitivity, per stage of cancer: I: 66% (n=29); II: 76% (n=21); Ill: 90% (n=10); IV: 75% (n=4).^1,2

^§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.¹

Indication and Important Risk Information Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease; or have a family history of colorectal cancer, or certain hereditary syndromes.

Positive Cologuard results should be referred to diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient.

False positives and false negatives do occur. In a clinical study, 13% of patients without colorectal cancer or advanced adenomas received a positive result (false positive) and 8% of patients with cancer received a negative result (false negative). The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

Cologuard performance when used for repeat testing has not been evaluated or established. Rx only.

References: 1. lmperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297. 2. Cologuard^® Physician Brochure. Madison, WI: Exact Sciences Corporation. 3. Ahlquist DA. Multi-target stool DNA test: a new high bar for noninvasive screening. Dig Dis Sci. 2015;60(3):623-633. 4. FDA Summary of Safety and Effectiveness Data: PMA P130017. Food and Drug Administration website. https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130017b.pdf. Updated August 11, 2014. Accessed November 12, 2019.

EXACT SCIENCES CORPORATION | 441 Charmany Drive | Madison, WI 53719

Cologuard is a registered trademark of Exact Sciences Corporation in the U.S. and other countries. EpicCare^® and EpicCare Link™ are trademarks of Epic Systems Corporation.

Significantly improved sensitivity over a leading fecal immunochemical test (FIT)* for detecting colorectal cancer and precancer1,2

The science behind Cologuard

Based on breakthrough stool DNA (sDNA) technology1,2

Cologuard

FIT*

Significantly improved sensitivity over a leading fecal immunochemical test (FIT)* for detecting colorectal cancer and precancer^1,2

Based on breakthrough stool DNA (sDNA) technology^1,2