Who Makes Cologuard: Everything You Need to Know

Cologuard is a non-invasive colorectal cancer screening test that can detect potential signs of cancer through stool analysis. It is an innovative way to test for colon cancer that has gained popularity in recent years. But who makes Cologuard? In this article, we’ll dive into the company behind the test, how it works, and why it’s important.

What is Cologuard?

Before we dive into who makes Cologuard, let’s first understand what it is. Cologuard is a home-based stool DNA test developed by Exact Sciences Corporation. The test is designed to detect DNA changes that may indicate the presence of colon cancer or precancerous polyps. It is a non-invasive test that can be done from the comfort of your own home, making it a convenient option for many people.

How does Cologuard work?

Cologuard works by analyzing DNA in your stool for certain genetic mutations and changes that may indicate the presence of cancer or precancerous polyps. The test also looks for blood in the stool, which can also be a sign of cancer.

To take the test, you will need to collect a stool sample at home using a kit provided by your healthcare provider. The kit includes a container for collecting your stool sample, as well as instructions for how to collect and ship the sample to a laboratory for analysis.

Once the laboratory receives your sample, they will use advanced technology to analyze the DNA and blood markers in your stool. If there are any concerning changes or mutations detected, your healthcare provider will recommend further testing or follow-up.

Who makes Cologuard?

Cologuard is made by a company called Exact Sciences Corporation. Exact Sciences is a healthcare company that specializes in developing and commercializing advanced diagnostic tests for a variety of medical conditions, including cancer.

The company was founded in 1995 and is headquartered in Madison, Wisconsin. Since the development of Cologuard, Exact Sciences has become a leader in the field of non-invasive cancer screening and has expanded its offerings to include other innovative diagnostic tests.

Why is Cologuard important?

Colon cancer is one of the most common types of cancer, and early detection is key to successful treatment. However, many people are hesitant to undergo traditional colonoscopies, which can be uncomfortable and require sedation.

Cologuard offers a non-invasive option for colon cancer screening that can be done from home, making it a convenient and accessible option for many people. The test is also highly accurate, with a sensitivity of 92% for detecting colon cancer and 69% for detecting precancerous polyps.

In addition to being a convenient and accurate screening option, Cologuard can also help detect colon cancer in its early stages, which can improve treatment outcomes and save lives.

How is Cologuard regulated?

Cologuard is regulated by the U.S. Food and Drug Administration (FDA). The test received FDA approval in 2014 and has since become a widely used option for colon cancer screening.

To receive FDA approval, Exact Sciences had to demonstrate the safety and effectiveness of Cologuard through rigorous clinical trials. The FDA also regularly monitors the safety and performance of the test to ensure that it continues to meet regulatory standards.

Can anyone use Cologuard?

Cologuard is approved for use in individuals who are between the ages of 45 and 85 and at average risk for colon cancer. It is not recommended for individuals who have a history of colon cancer or certain other medical conditions.

However, it is important to note that Cologuard is not a replacement for regular colonoscopies. If you have a family history of colon cancer, a personal history of polyps or other medical conditions, or are experiencing symptoms like abdominal pain or rectal bleeding, your healthcare provider may recommend a colonoscopy instead of or in addition to Cologuard.

How much does Cologuard cost?

The cost of Cologuard varies depending on your insurance coverage and other factors. However, on average, the test costs around $600.

Many insurance plans cover Cologuard as a preventive screening option, but it is important to check with your provider to understand your specific coverage and any out-of-pocket costs you may incur.

Final thoughts

Cologuard is an innovative and convenient option for colon cancer screening that has the potential to save lives by detecting cancer and precancerous polyps early. It is made by Exact Sciences Corporation, a healthcare company that specializes in developing advanced diagnostic tests.

While Cologuard is not a replacement for regular colonoscopies, it is an important option for individuals who are at average risk for colon cancer and may be hesitant to undergo traditional screening methods. If you are interested in learning more about Cologuard or other colon cancer screening options, talk to your healthcare provider to determine which option is right for you.