COMPONENTS
SAMPLE LABELSPATIENT GUIDE INSTRUCTIONS
SHIPPING BOX SAMPLE CONTAINER
PROBE + TUBE
BOTTLE OF LIQUID
(PRESERVATIVE)
BRACKET
The Cologuard Collection Kit is easy to use. If a patient has questions,
a live Customer Support Specialist is available to assist via phone: 1-844-870-8870.
What’s inside:
Patients can watch a short, helpful video on how to use
the collection kit at Cologuard.com/use
.
THE COLOGUARD
®
COLLECTION KIT
EASY STEPS
FOR SAMPLE COLLECTION
Cologuard is ready to use when
you are ready to use it.
1
SIT
Use the kit components to
collect your sample.
2
SCRAPE
Fill the sample container with
the liquid preservative.
3
SOAK
Ship your sample to complete
the process.
4
SHIP
Patients collect a single stool sample at home and send to
Exact Sciences Labs via prepaid UPS shipping or pick-up
Order forms are available online at CologuardHCP.com/resources or by calling 1-844-870-8870.
Indications 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.
EXACT SCIENCES CORPORATION
5505 Endeavor Lane, Madison, WI 53719
ExactSciences.com | ExactLabs.com | 1-844-870-8870
Cologuard is a registered trademark of Exact Sciences Corporation.
©2021 Exact Sciences Corporation. All rights reserved. US.CG.2908-4-January 2021
COMPONENTS
