By: Tameka N. Jones DNP, MBA, RN, NEA-BC

Medical Science Liaison, Exact Sciences

CRC Prevalence

Colorectal cancer is considered one of the most preventable yet least prevented cancer.1 The American Cancer Society estimates that in 2025 there will be 154,000 new cases of colorectal cancer and 53,000 deaths in the United States.2 In Alabama, there are an estimated 2,630 new cases with approximately 920 deaths, which includes both men and women.3

Screening Options/Considerations

Despite progress with screening efforts, an estimated 60 million eligible Americans are not up to date with current colorectal screening recommendations. National guidelines exist for individuals at average risk, defined as those without a personal history of colorectal cancer or certain types of polyps, a family history of colorectal cancer, a personal history of inflammatory bowel disease, a confirmed or suspected hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or Lynch syndrome(hereditary non-polyposis colon cancer or HNPCC), or a personal history of radiation to the abdomen or pelvic area.2 It is important to consider whether your patient is average risk or high risk when considering the appropriate screening method for colorectal cancer.

Cologuard® /Cologuard Plus ™

At Exact Sciences, our purpose is to help eradicate cancer by preventing it, detecting it earlier, and guiding personalized treatment.5

The Cologuard test, approved in 2014, was the first noninvasive CRC screening test that identifies biomarkers and blood in the stool associated with CRC and advanced adenomas. The Cologuard test is indicated for individuals aged 45 years and older at average risk for CRC.6 Cologuard key advantages include its ease of use—patients collect a stool sample at home and send it to an Exact Sciences’ lab for analysis—and its ability to detect colorectal neoplasia associated DNA and pre-cancerous lesions even in asymptomatic individuals. The Deep-C study demonstrated that the Cologuard test has a sensitivity of 92.3% for detecting CRC, and 42.4% for advanced precancerous legions.7

Exact Sciences launched the Cologuard Plus™ test on March 31, 2025. The Blue-C study validated the performance for the Cologuard Plus test, which includes new biomarkers for colorectal cancer. The test demonstrated CRC sensitivity of 95%, age weighted specificity of 94% for lack of cancer and precancer, and 43% sensitivity for advanced precancerous lesions. With enrollment of over 26,000 participants, this was one of the largest CRC screening studies directly comparing multiple screening tests conducted in the US. Notably, the Blue-C study population closely resembled the U.S. general population with respect to racial and ethnic distribution. In addition, Exact Sciences retained blood samples from the BLUE-C study for investigation of a blood-based colorectal cancer screening test that is currently under development.8

Coverage

As economic stability, health care access, quality and other social determinants of health play a key part in patient outcomes in CRC, coverage of noninvasive screening options is top of mind for most health systems and providers.9 Currently the Cologuard Plus test is covered for Medicare Part B patients, and the company is working to expand insurance access on other plans. Patients and providers are encouraged to ask their individual insurers about coverage. Additionally, federal guidance requires commercial health plans under the Affordable Care Act to cover follow up colonoscopy after a positive, non-invasive CRC screening test without patient cost share, Medicare coverage follows similar guidelines.10 In addition, the Cologuard and the Cologuard Plus tests include nationwide patient navigation and customer support services to facilitate the completion of screening.6

For more information about colorectal cancer, screening and Cologuard visit Exact Academy at: exactsciences.com/exact academy.

References are on file at Exact Sciences and available by request.

Important Information about the Cologuard products Indications for Use

The Cologuard® and Cologuard Plus™ tests are 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)/advanced precancerous lesions (APL) and should be followed by a colonoscopy. The Cologuard test and Cologuard Plus test are indicated to screen adults of either sex, 45 years or older, who are at average risk for CRC. These tests are not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Contraindications

The Cologuard products are not for high-risk individuals, including patients who have the following:

• a personal history of colorectal cancer and adenomas
• a positive result from another colorectal cancer screening method within a test recommended timeframe
• have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease

• have a family history of colorectal cancer, or certain hereditary syndromes

Warnings and Precautions

All positive results should be referred to colonoscopy. The Cologuard products may produce false positive and false negative results. A false positive result occurs when a

result is positive, even though a colonoscopy will not find CRC or APL. A false negative result occurs when a result is negative, even when a colonoscopy identifies APL or CRC.

A negative result does not guarantee the absence of colorectal 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. Performance when used for repeat testing has not been established.

Refer to the Cologuard test Clinician Brochure or the Cologuard Plus test Clinician Brochure for additional information about the benefits and risks of using each version of the Cologuard product for CRC screening. (Link to each Clinician Brochure within the text)Rx only.

References

1. Itzkowitz SH J Natl Cancer Inst. 2009;101(18):1225-1227
2. About Colorectal Cancer. Accessed April 18, 2025. https://www.cancer.org/content/dam/CRC/PDF/Public/8604.00.pdf
3. Siegel RL, Giaquinto AN, Jemal Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49.
4. American Cancer Society Guideline for Colorectal Cancer Screening. Accessed April 15, 2025.
5. Exact About Us. https://www.exactsciences.com/about Accessed April 15, 2025.
6. Cologuard Plus Clinician Madison, WI: Exact Sciences Corporation.
7. Imperiale TF, et N Engl J Med.2014;370(14):1287-1297
8. Cologuard Clinician Exact Sciences. Madison , WI
9. Office of Disease Prevention and Health Promotion. Social Determinants of Health. Accessed February 14, 2025. https://health.gov/healthypeople/priority-areas/social-determinants-health
10. FAQs About Affordable Care Act Implementation Part 51, Families First Coronavirus Aid. Relief and Economic Security Act Implementation.