What is Cologuard?
Cologuard is a non-invasive colon cancer screening test offered by Exact Sciences Corporation , a company based in the United States. The test can be ordered by a healthcare provider and is designed to detect DNA mutations and blood biomarkers in a patient's stool sample, which may be signs of potential colon cancer or precancer.
The test is recommended for patients at average risk of colon cancer, who are aged 45 and above. It is a preferable alternative for those who do not want to undergo a colonoscopy, or who may not be able to undergo one due to certain medical conditions. The Cologuard test is easy to use and can be completed in the comfort of a patient's home. The process involves collecting a stool sample using a kit provided by the lab, and then sending the kit back for analysis.
Results are typically available within two weeks of the lab receiving the sample, and are sent directly to the healthcare provider who ordered the test. A positive result does not necessarily mean a patient has colon cancer but may indicate the need for further testing. Patients are advised to discuss their results with a healthcare provider as soon as possible.
If you are interested in obtaining the Cologuard test, you can speak with your healthcare provider to determine if it is right for you. Exact Sciences also offers resources on their website and a patient support program to assist patients throughout the testing process.
Frequently Asked Questions about cologuard
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.
Exact Sciences Corporation
Exact Sciences Corporation provides cancer screening and diagnostic test products in the United States and internationally. The company offers Cologuard, a non-invasive stool-based DNA screening test to detect DNA and hemoglobin biomarkers associated with colorectal cancer and pre-cancer.
How accurate is the Cologuard test? Cologuard can detect 92% of cancers but only 42% of large precancerous polyps. Cologuard is better at detecting cancer than FIT (92% versus 74% for FIT), but the false positive rate is higher.
Exact Sciences Corp. is a molecular diagnostics company specializing in the detection of early stage cancers. The company's initial focus was on the early detection and prevention of colorectal cancer, in 2014 it launched Cologuard, the first stool DNA test for colorectal cancer.
The cost is around $500. Some insurance plans may cover part of that cost depending on your plan, co-pay, and deductible. Diagnostic testing is subject to deductibles and coinsurance. Screening colonoscopies are not subject to copays and deductibles and usually have no out-of-pocket costs for patients.
Is Cologuard FDA approved? Yes, Cologuard was approved by the FDA in August 2014 after undergoing a rigorous review process known as a Pre-Market Approval (or PMA).
Pfizer established an agreement with Exact Sciences Corporation, a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer, to co-promote Cologuard®, the first and only noninvasive stool DNA screening test for colorectal cancer approved by the U.S. Food and Drug ...
Cologuard is a stool-based test and also can be known as the fecal immunochemical test (FIT). These stool-based tests can be done at home have a much higher sensitivity and specificity for colon cancer. Cologuard looks for blood in your stool, precancerous polyps or abnormal DNA.
Cologuard can detect 92% of cancers but only 42% of large precancerous polyps. In other words, no, it is not accurate, especially when it comes to preventing cancer by detecting polyps. While it is better at detecting cancer than FIT (92% vs 74% for FIT), the false positive rate is higher.
Cologuard's accuracy rate for detecting colorectal cancers and precancerous polyps is touted to be 92%. While that is impressive for a stool-based test, it still means that 8% of lesions will go undetected, leaving those patients with a false sense of security. Cologuard has a 14% false-positive rate.
Madison, Wisconsin
Take this virtual tour for a sneak peek inside Exact Sciences Laboratories in Madison, Wisconsin. Learn how this innovative, customer-focused, mission-driven facility delivers colorectal cancer screening results for patients nationwide with Cologuard.
Why does the Cologuard test cost more? The base cost of the test is higher than the cost of other recommended at-home tests for colon cancer screening. The Cologuard test combines a fecal immunochemical test (FIT Test) with a patented DNA test. Premera pays for preventive care as required by the Affordable Care Act.
The downside – A study in the New England Journal of Medicine reported that 13% of Cologuard results were false positives while 8% were false negatives. This means that a patient may be referred for further testing without having cancer or could have cancer and not know it.
The test is done to screen for colon and rectal cancer and abnormal growths (polyps) in the colon or rectum. Your provider may suggest Cologuard testing once every 3 years after age 50 years. The test is recommended if you are between ages 50 to 75 years and have an average risk of colon cancer.
False positives and false negatives can occur. In a clinical study, 13% of people without cancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative). It is important to talk to your doctor about your test results.
The test is done to screen for colon and rectal cancer and abnormal growths (polyps) in the colon or rectum. Your provider may suggest Cologuard testing once every 3 years after age 50 years. The test is recommended if you are between ages 50 to 75 years and have an average risk of colon cancer.
