Cologuard is not available over the counter. It requires a prescription from a doctor or other licensed healthcare provider, even though you complete the test entirely at home. You cannot walk into a pharmacy or order the kit online without a provider’s order.
Why a Prescription Is Required
Cologuard is an FDA-approved medical diagnostic test, not a consumer wellness product. It analyzes stool samples for DNA markers and traces of blood associated with colorectal cancer. Because the results carry real clinical weight and may lead to follow-up procedures like a colonoscopy, the FDA classifies it as a prescription device. A provider needs to review whether the test is appropriate for you before ordering it.
If you want to get started, Exact Sciences (the company behind Cologuard) offers a form on its website that generates a customized order you can bring to your doctor. From there, your provider submits the prescription, and the kit ships directly to your home.
Who Qualifies for the Test
Cologuard is designed for people at average risk of colorectal cancer, generally between ages 45 and 85. “Average risk” has a specific meaning here: no personal history of colon polyps, colorectal cancer, or inflammatory bowel disease (such as Crohn’s or ulcerative colitis), and no family history of colorectal cancer or certain hereditary syndromes. You also need to be asymptomatic, meaning no blood in your stool, no lower gastrointestinal pain, and no prior positive results on other stool-based screening tests.
If you fall outside those criteria, your doctor will likely recommend a colonoscopy or another screening method instead.
What Happens Once You Get the Kit
The kit arrives with a bracket that sits on your toilet, a collection container, a small tube with a probe, a bottle of liquid preservative, and shipping materials. You have a bowel movement into the container, scrape the surface of the sample with the probe and seal it in the tube, then pour the preservative liquid into the container and seal that as well. Both items get labeled with your name, birthdate, and the date and time of collection, then packed into the provided box for shipping.
Timing matters. The lab must receive your sample within 72 hours of collection, so plan to ship it the same day you collect it. The kit includes prepaid shipping labels.
How Accurate Cologuard Is
In its pivotal clinical study, Cologuard detected 92.3% of colorectal cancers, using colonoscopy as the reference standard. That’s strong for a noninvasive, at-home test. Its specificity was 86.6%, meaning about 13 out of 100 people without cancer or advanced polyps will get a false positive result that triggers an unnecessary colonoscopy.
For advanced precancerous polyps (called advanced adenomas), the detection rate drops to about 42%. That’s significantly better than the simpler stool blood test (FIT) but far less sensitive than colonoscopy. A negative Cologuard result doesn’t guarantee you’re polyp-free, which is one reason regular rescreening matters.
How Often You Need to Repeat It
The U.S. Preventive Services Task Force recommends repeating Cologuard every one to three years. Medicare currently covers the newer version, Cologuard Plus, once every three years for eligible patients ages 45 to 85. Your provider will help determine the right interval based on your individual risk profile and which version of the test you’re using.
Cost and Insurance Coverage
Without insurance, Cologuard costs $600 or more. Most people don’t pay that. Medicare covers the test with no deductible and no coinsurance for patients who meet the eligibility criteria. Most private insurers also cover colorectal cancer screening at no out-of-pocket cost under the Affordable Care Act’s preventive care provisions, though the specific terms vary by plan.
If you’re uninsured, Exact Sciences offers a patient assistance program that may reduce or eliminate the cost. Your provider’s office can typically help you navigate this before the kit is ordered, so you aren’t surprised by a bill after the fact.