Cologuard: The Stool DNA-Based Approach

Cologuard is a disruptive technology in the war on colon cancer. As a non-invasive frontline screening test, it is FDA-approved and covered by Medicare and an increasing number of commercial payers. In a 10,000-patient clinical trial, Cologuard found 92% of cancers, 42% of pre-cancers and had a specificity of 87%.

Cologuard is so easy to use that you can do it from home. The test does not require you to follow a special diet or change your medications.

Here’s how it works.



The Exact Sciences Customer Care Center is dedicated to ensuring patients comply with colon cancer screening.  Our team works to ensure that shipped Cologuard kits result in completed tests.

Open 24/7, 365 days a year our Madison, Wisconsin-based Customer Care Center is staffed by helpful, knowledgeable technicians who support both physicians and patients during the screening process.



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 or advanced adenoma and should be followed by a diagnostic colonoscopy. Cologuard is indicated to screen men and women 50 years or older, who are at typical average-risk for colorectal cancer. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals. Both false positives and false negatives do occur. In the clinical study of Cologuard, 13% of people without cancer or precancer tested positive. Any positive result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established.

Cologuard is not for everyone. Cologuard is not a replacement for diagnostic or surveillance colonoscopy in patients at high risk for colorectal cancer. Both false positives and false negatives do occur. Any positive should be followed by a 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. Cologuard performance when used for repeat testing has not been evaluated or established. Cologuard results should be interpreted with caution for individuals over age 75 as the rate of false positive results increases with age. Patients should not provide a sample for Cologuard if they have diarrhea or if they have blood in their urine or stool (e.g., from bleeding hemorrhoids, bleeding cuts or wounds on their hands, rectal bleeding, or menstruation). Rx Only.

References
  1. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(4):1987-97.