frequently
asked questions

What is Cologuard?

Cologuard is an easy to use, noninvasive colon cancer screening test that you can use in the privacy of your own home. It identifies altered DNA and/or blood in stool, which are associated with the possibility of colon cancer or precancer. Your healthcare provider will talk with you about your results. For more about understanding results, click here.

How do you get DNA out of stool?

DNA is continuously shed from cells in the intestinal lining, where it is passed into the stool. If cancer or precancer is present, abnormal cells will shed into the colon and stool along with normal cells. We use a molecular biology process to capture specific pieces of DNA for further analysis. 

Why does Cologuard use stool samples and not blood samples?

DNA is continuously shed from cells in the intestinal lining and passed into the stool. Both precancer and cancer shed DNA, so it can be an early indicator of the presence of colon cancer or precancerous lesions, before altered DNA would be present in the blood stream.

Is Cologuard a genetic test?

No. Cologuard is not a test to confirm or deny a suspected genetic condition, or help determine a person's chance of developing or passing on colon cancer. Cologuard does not provide information about DNA changes that are inherited or can be passed on to your children. Cologuard identifies DNA mutations that are acquired over time in cells lining the colon; these mutations can be associated with the presence of colon cancer or precancerous lesions.

How was Cologuard developed?

Cologuard was developed by Exact Sciences in collaboration with researchers at the Mayo Foundation for Medical Education and Research. It went through extensive research and development, including a clinical study of 10,000 average risk study participants that validated the test's safety and efficacy in screening for colon cancer and precancer.

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).

How effective is Cologuard?

In a clinical study of 10,000 participants ages 50 -84 years old, of average risk for colon cancer, Cologuard found 92% of cancer. Cologuard was negative in 87% of participants without cancer or advanced precancerous lesions. 

Should colonoscopy be used in addition to Cologuard?

Cologuard is a screening test. Any positive result should be discussed with your healthcare provider and followed by a diagnostic colonoscopy.

How often should Cologuard be used?

The American Cancer Society (ACS) includes multi-target stool DNA (Cologuard) as one of the CRC screening options for average risk adults ages 45 and older. ACS recommends Cologuard every 3 years.

Colon cancer screening guideline recommendations vary for people under the age of 50 and over the age of 75. The decision to screen people over the age of 75 should be made in consultation with a healthcare provider. The rate of false positive Cologuard results increases with age. Talk to your healthcare provider about what screening program is appropriate for you.

Is Cologuard included in the United States Preventive Services Task Force (USPSTF) guidelines? What does this mean?

Yes, Cologuard is included in the United States Preventive Services Task Force (USPSTF) guidelines on colon cancer screening as of its June 2016 update. The USPSTF strongly recommends colon cancer screening for people aged 50-75 (‘A’ rating), meaning the committee finds a substantial net benefit in colon cancer screening.

Cologuard is included on equal standing among the other 'A rated' colon cancer screening options, including colonoscopy, CT colonography, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, gFOBT, and FIT. Read the USPSTF’s guidance on colon cancer screening in full by visiting its website.

Is Cologuard included in the Healthcare Effectiveness Data and Information Set (HEDIS) quality measures? Why does this matter?

Yes, stool DNA (i.e. Cologuard) is one of the methods permitted as part of the National Committee for Quality Assurance’s (NCQA) Healthcare Effectiveness Data and Information Set* (HEDIS®) quality measure for colon cancer screening. HEDIS is a helpful tool used by more than 90% of health plans in America. The quality measures analyze the performance of healthcare services and care. The data and results are used to make improvements in the healthcare provider's quality of care and service.

*Third party guidelines do not specifically endorse commercial products, and inclusion in guidelines does not imply otherwise.

Who can get screened with Cologuard?

If you are 45 and older and at average risk for colon cancer, Cologuard may be right for you. Cologuard is not for everyone. It is not a replacement for diagnostic or surveillance colonoscopy in high risk individuals. It may not be right for you if:

• You have a personal history of colon cancer, adenomas or other related cancers
• You have a family history of colon cancer (one or more first degree relatives diagnosed with colon or rectal cancer before the age of 60, or two or more first degree relatives diagnosed with colon or rectal cancer of any age)
• You have had a positive result from another screening method in the last six months
• You have been diagnosed with a condition that places you at high risk for colon cancer. These include but are not limited to: Inflammatory Bowel Disease, Chronic ulcerative colitis, Crohn’s disease, Familial adenomatous polyposis
• You have been diagnosed with a relevant cancer syndrome passed on from your family, such as Hereditary non-polyposis colorectal cancer syndrome, Peutz-Jeghers Syndrome, MYH-Associated Polyposis, Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis
• Results should be interpreted with caution for individuals over age 75, as the rate of false positives increases with age

For complete information on Cologuard, please click here.

If one of my family members had colon cancer, is this test right for me?

Cologuard is approved for use by adults 45 years of age and older, who are at average risk for colon cancer. It may not be right for you if you have a family history of colon cancer (one or more first degree relatives diagnosed with colon or rectal cancer before the age of 60, or two or more first degree relatives diagnosed with colon or rectal cancer of any age). Please discuss your overall screening plan with your healthcare provider to determine what is right for you.

Can I use Cologuard if I have hemorrhoids, menstrual period or blood in the stool?

Cologuard should not be used by those who have or may have blood in their stool due to actively bleeding hemorrhoids, menstruation, or other existing conditions, as this may result in a false positive result. Please discuss your overall screening plan with your healthcare provider to determine what is right for you.

If I have mobility issues, will I have a problem with the test?

Collecting a sample for Cologuard involves sitting on a toilet and having a bowel movement, as well as opening bottles and containers. If you typically need assistance using the bathroom or opening containers, you may need assistance while collecting the sample.

Do I need to do anything to prepare for this test?

Please carefully read the instructions that arrived with the Cologuard Collection Kit prior to collecting the sample. No other special preparation is required.

Do I need to stop taking any medications prior to using the test?

No, there is no need to stop any medications prior to collecting a sample for Cologuard.

Are there any dietary restrictions for this test?

No, there are no known dietary issues or restrictions that would interfere with an accurate Cologuard result.

What comes in the test kit? Where will I get it?

After our lab receives the completed order from your healthcare provider, we will send the Collection Kit to the address provided. We may need to contact you ahead of shipment if any information is missing. Once you receive the Collection Kit, it will include instructions for collecting a sample, a prepaid return shipping label, and Exact Sciences Laboratories phone number, in case you have any additional questions.

Can Cologuard be taken in my healthcare provider's office?

We deliver the collection kit to your home address, so you can collect a sample privately and easily. If you prefer to collect your sample at your healthcare provider's office, please contact him or her to see if he or she can accommodate your request.

What if I don't have a permanent address?

We need an address where you can receive the kit, but it doesn’t need to be your permanent address.

Can Cologuard be mailed to a PO Box?

Yes. Although we would prefer to ship a kit to your physical address, we can send your kit via UPS to your PO Box if that is where you normally receive packages. Please note you will still need to contact UPS to schedule a pickup or drop your sample off at a UPS location, once you have collected your sample.

How should I send the collection kit back to the lab?

The Collection Kit (with the sample inside) should be mailed back to our lab via UPS, using the original box and prepaid and pre-addressed return label that we provide.

You can drop off the kit at any UPS store or shipping location, or you can call 1-800-823-7459 to schedule a pick-up at your home. Please note that the sample must be shipped within 24 hours of collection, and received by our lab within 72 hours of collection. We recommend shipping it Monday through Thursday for this reason.

If I schedule a UPS pick-up, do I need to be home at that time?

No, you do not need to be at home at the pick-up time if you leave the shipping box in an easy-to-see location, such as near the front door. Please note that the sample must be shipped within 24 hours of collection, and received by our lab within 72 hours of collection. We recommend shipping it Monday through Thursday for this reason.

I received a kit but it is damaged (or missing a part). What should I do?

Please call Exact Sciences Laboratories Customer Support Center at 1-844-870-8870. Our support specialists will confirm your information and help determine if a new kit should be sent to you.

I received a kit but I made a mistake collecting my sample. What should I do?

Please call Exact Sciences Laboratories Customer Support Center at 1-844-870-8870. Our support specialists will confirm your information, and help determine if your sample can still be used or if a new kit should be sent to you.

I could not mail my test for a few days after taking it. Is that okay?

Our lab needs to receive the sample within 72 hours following collection to ensure test accuracy, so we recommend shipping it within 24 hours of collection. If you are concerned that your sample will not arrive within 72 hours of collection, please call Exact Sciences Laboratories Customer Support Center at 1-844-870-8870.

How will I know if my sample is "normal"?

It is most important to get a 'typical sample' for you.  For example, if you normally have loose stool, go ahead and take the test. If you do not normally have loose stool, it is best to wait until the stool returns to its normal consistency. However, if you are sick and have diarrhea, you should not collect a sample. If you have any specific concerns, please call Exact Sciences Laboratories Customer Support Center at 1-844-870-8870.

How should I store the sample before returning it to the lab?

Samples should be stored in the Cologuard Collection Kit at room temperature, and returned to our lab within 72 hours from the time of collection. 

How long does it take to receive the results?

Your Cologuard test result will typically be delivered to your healthcare provider within two weeks of our lab receiving a sample. If you returned your sample to the lab more than two weeks ago but still haven’t received your results, please call Exact Sciences Laboratories Customer Support Center at 1-844-870-8870.

What does a positive result mean? A negative result?

A positive result does not necessarily mean that you have cancer. It means that Cologuard detected DNA and/or hemoglobin biomarkers in the stool which are associated with colon cancer or precancer. False positive and false negative result occur with Cologuard and appropriate follow-up is important. Patients with a positive result should have a diagnostic colonoscopy. Patients with a negative diagnostic colonoscopy following a positive Cologuard result do not require additional clinical evaluation and should continue in a screening program appropriate for you, recommended by your healthcare provider.

A negative result means that Cologuard did not detect significant levels of DNA and/or hemoglobin biomarkers in the stool which are associated with colon cancer or precancer. False positives and false negatives occur with Cologuard and appropriate follow-up is important. If you have a negative result, you should continue in a screening program appropriate for you, recommended by your healthcare provider. Cologuard is recommended by the American Cancer Society every 3 years.

Can Cologuard be used for people ages 45-49?

Yes. Cologuard is now approved to screen adults 45 years old and older at average risk for colorectal cancer. This does not include individuals who have a personal or family history of CRC, have IBD, personal history of adenomas; have a relevant familial (hereditary) cancer syndrome or have had a previous positive CRC screening result in the past 6 months. Patients should talk to their healthcare provider to determine if Cologuard is appropriate for them. 

I thought CRC screening was supposed to start at age 50. Why is it changing?

In May 2018, the American Cancer Society revised its CRC screening guidelines to include patients 45 years or older at average risk of CRC. The ACS based this recommendation on increased CRC incidence and mortality rates in this population. 

How can I get Cologuard?

Cologuard is a noninvasive screening option that is available by prescription only. Call or make an appointment with your healthcare provider to request Cologuard.

Will my insurer cover the test?

Currently, ~74% of Cologuard patients 45-49 have had no out-of-pocket cost for screening.

• Many national and regional payers have begun paying for CRC screening at 45. Exact Sciences continues to work with payers to expand coverage and access for patients ages 45-49.

Visit the insurance page for more details by clicking here.

Exact Sciences estimate based on historical patient billing. Rate of coverage varies by state and region. Exceptions for coverage may apply, only your insurer can confirm how Cologuard would be covered for you.

How much does this test cost?

As of March 2017, the list price of Cologuard is $649. Insurance may cover some or all of that amount depending on the patient's insurance plan and benefits. We highly recommend that you call your insurer to ask whether your plan covers Cologuard and what if any out-of-pocket cost you may have prior to taking the test. You may also want to ask if there is any paperwork to file, such as a prior authorization, before using the test.

What methods of payment are accepted?

We accept personal check, Visa, Mastercard, Discover, American Express.

If you’ve received a bill from Exact Sciences Laboratories, you can pay via mail, online or phone by calling our Customer Care Specialists at 1-844-870-8870.

If paying by mail, please remember to include your payment stub and write your order number on the check. The order number can be found near the top of your bill.

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What are the CPT, HCPCS, ICD-10 Codes, Tax ID, NPI, and Diagnosis Codes for Cologuard?

Cologuard is only billed under CPT code 81528. This code was established by the American Medical Association CPT Editorial Panel (and recognized by Medicare) with an effective date of 1/1/2016. It is also known as a HCPCS Level I or CPT Category I code.

Cologuard, Exact Sciences Laboratories Tax ID: 46-3095174

Cologuard, Exact Sciences Laboratories NPI: 1629407069