COVID-19 Response

In light of the developments of COVID-19, we want to proactively provide information that may be useful to providers at this time as it relates to screening for colorectal cancer (CRC).

Exact Sciences Laboratories remains fully operational. Plans are in place at all sites to help sustain operations and ensure service for patients during this unprecedented time. Read this letter from our CEO, Kevin Conroy, to learn about what we’re doing as a company to operate safely and effectively.

Because Cologuard®, a non-invasive CRC screening option for average-risk adults 45 and older, can be done entirely at home, testing with Cologuard can continue during the current pandemic, even while people are staying home to avoid exposure to or spreading the virus. After Cologuard is prescribed, the collection kit can be sent directly to the patient’s home and picked up by UPS® without social interaction. As telehealth is evolving to meet the needs of the current environment, we also see the benefit of telehealth in playing a role in CRC screening. As a result, we are making consumers aware of not only existing resources to discuss CRC screening with Cologuard with their provider, but also information about telehealth in general, and a link to one such third party, independent telehealth provider from whom they may request Cologuard to see if it is right for them.

Below, we seek to answer questions that have emerged about recommending Cologuard during the COVID-19 outbreak.

For additional questions about Cologuard, please call the Customer Care Center 24/7
at 1-844-870-8870.

  • Why is CRC screening still important during the COVID-19 pandemic?

    The COVID-19 pandemic has demanded the attention of many aspects of healthcare. While this is a crucial part of the national response, the shift in focus away from health maintenance and preventive care during the pandemic will also negatively affect our communities. Colorectal cancer (CRC) is the second-leading cause of cancer deaths1 in both men and women at age 50 years and older, yet it is one of the most preventable cancers in the US.2 It is critically important to detect CRC in its earliest stages, when it is most treatable.3*

    • There is a 90% survival rate at 5 years when CRC is detected in its earliest stages. The survival rate declines to only 14% when CRC is detected in its most advanced stage.1‡
    • With 44 million eligible people still not getting screened as recommended, a significant opportunity remains in the fight against CRC through early detection.

    Non-invasive CRC screening tests, such as Cologuard®, can identify individuals who test positive, which means they have an increased likelihood of CRC or advanced precancer.6 A positive Cologuard result can help clinicians prioritize follow-up colonoscopy testing when healthcare accessibility allows. Most results will be negative in average-risk individuals, which means they have a lower likelihood of having CRC.6 Negative test results can help remove pressure on the healthcare system, while positive test results should be prioritized for follow-up colonoscopy.

    For additional questions about Cologuard, please call the Customer Care Center
    at 1-844-870-8870
    .

    Footnotes

    *Based on 5-year survival.

    Based on people diagnosed with CRC in stage I stage IIa, or stage IIb between 2008 and 2014.

    Localized: There is no sign that the cancer has spread outside of the colon or rectum. This includes AJCC stage I, IIa, and IIb cancers. Regional:The cancer has spread outside the colon or rectum to nearby structures or lymph nodes. This includes stage IIc and stage III cancers in the AJCC system. Distant: The cancer has spread to distant parts of the body such as the liver, lungs, or distant lymph nodes. This includes stage IV cancers.4

    §Estimate based on the US population aged 45-74, adjusted for the reported rates of high-risk conditions and CRC screening.

    References

    1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654.

    2. Itzkowitz SH. Incremental advances in excremental cancer detection tests. J Natl Cancer Inst. 2009:101(18): 1225-1227.

    3. National Cancer Institute. Cancer stat facts: Colorectal cancer. https://seer.cancer.gov/statfacts/html/colorect.html. Accessed February 17, 2021.

    4. American Cancer Society. Survival Rates for Colorectal Cancer, by Stage. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html. Accessed February 17, 2021.

    5. Piscitello A, Edwards DK. Estimating the screening-eligible population size, ages 45-74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res. 2020;13(5):443-448. doi:10.1158/1940-6207.CAPR-19-052.

    6. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.

  • What does a positive Cologuard® result mean, especially in the current COVID-19 environment?

    A positive Cologuard® result

    Individuals who receive a positive Cologuard result may, understandably, be concerned about the effect of the COVID-19 environment on their next steps. They are now indicated for follow-up colonoscopy because of the increased chance of colorectal cancer (CRC) or advanced precancer. However, a positive Cologuard result is not a diagnosis of cancer or precancer. In the pivotal Cologuard study of 10,000 patients, 16% of the patients had a positive result with the following distribution of findings:1

    4%

    had CRC

    20%

    had advanced precancer

    31%
    had non-advanced precancer
    45%
    had no cancer or precancer

    In the same clinical study, 84% of patients had a negative result. Of those patients, there was a 99.94% chance that no CRC was present.1

    Table 3: Extrapolation of findings to an expanded population of 10,000 patients aged 50-84 years at average risk for colorectal cancer undergoing screening with colonoscopy, Cologuard, and FIT*, published in The New England Journal of Medicine1

    99.94% of persons with a negative Cologuard result did not have CRC on colonoscopy

    *OC FIT-CHEK, Polymedco, Inc.

    Reference: 1. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.

    With this clinical profile, Cologuard is an effective way to triage patients for follow-up care. Screening-positive patients should be prioritized for follow-up colonoscopy, but they should understand that they do not necessarily have cancer. Screening-negative patients can be reassured that CRC is highly unlikely to be present.1

    A positive result in the current COVID-19 environment:

    If a patient has a positive Cologuard result, they should get a follow-up colonoscopy as soon as possible.  Under normal circumstances, follow-up colonoscopy within 3 months of a positive stool test has been recommended.2 During the COVID-19 pandemic, the major GI societies (AASLD, ACG, AGA, ASGE) have advised that, for most asymptomatic patients with either a positive Cologuard or FIT test, “colonoscopy should be considered non-urgent and can be delayed by at least 4-6 weeks and reassessed.”3 

    Given the unprecedented time and the potential delays associated with follow-up colonoscopy, an external literature search was conducted to assess other relevant data that may be useful to providers during this time.  One such dataset involves immunochemical fecal occult blood tests (FIT)—a different type of non-invasive stool CRC screening test. In a retrospective cohort study of 70,124 FIT-positive patients, Corley et al. found that "there was no significant increase in risk of colorectal cancer outcomes for examinations within 6 months,” compared with follow-up colonoscopy at 8 to 30 days.4

    If a delay in follow-up colonoscopy evaluation could cause undue anxiety for any of your patients, you may wish to discuss the pros and cons of screening for colorectal cancer with them at this time.

    References

    1. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.

    2. Doubeni CA, Gabler NB, Wheeler CM, et al. Timely follow-up of positive cancer screening results: A systematic review and recommendations from the PROSPR Consortium. CA Cancer J Clin. 2018;68(3):199-216.

    3. ACG. COVID-19 and GI. Gastroenterology Professional Society Guidance on Endoscopic Procedures During the COVID-19 Pandemic. https://gi.org/media/covid-19-and-gi/ Accessed February 17, 2021.

    4. Corley DA, Jensen CD, Quinn VP, et al. Association Between Time to Colonoscopy After a Positive Fecal Test Result and Risk of Colorectal Cancer and Cancer Stage at Diagnosis. JAMA 2017;317:1631–1641.

  • FAQs for Colorectal Cancer Screening During the COVID-19 pandemic

    Is colorectal cancer (CRC) screening still important right now?

    Yes. Colorectal cancer continues to affect our communities, even as they are affected by the COVID-19 pandemic.

    It is the second-deadliest cancer among men and women in the US, even though it is one of the most preventable cancers.1,2 Early detection of CRC is associated with significantly higher survival rates compared to late detection,1 yet 44 million eligible people are still not getting screened as recommended.3* A decline in cancer preventive care now may negatively impact our communities in the future.

    *Estimate based on the US population aged 45 to 74 years as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.

    References: 1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654. 2. Itzkowitz SH. Incremental advances in excremental cancer detection tests. J Natl Cancer Inst. 2009;101(18):1225-1227. 3. Piscitello A, Edwards DK. Estimating the screening-eligible population size, ages 45-74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res. 2020;13(5):443-448. doi:10.1158/1940-6207.CAPR-19-052.

    Is Exact Sciences still conducting Cologuard® testing?

    Yes. As a company, we take our responsibility to protect our patients, our partners, and our team very seriously. As such, we have had procedures and protocols in place to safely handle clinical testing specimens both at Exact Sciences Laboratories and during sample transport. Our procedures include utilizing universal precautions when handling specimens to protect against stool pathogen exposure, including COVID-19. Exact Sciences performs functions that are essential to the community’s well-being, including healthcare and laboratory services. Cologuard testing will continue for any specimens that are submitted, and the Customer Care Center will continue to assist you and your patients with any questions or concerns.

    Will UPS® still pick up a Cologuard® collection kit from a patient’s home?

    Yes. UPS® will continue to pick up your patient’s completed Cologuard® collection kit, except where limited by government restrictions. Cologuard shipments have not been affected. Your patients can schedule a UPS pickup in several ways, including calling the Customer Care Center at 1-844-870-8870.

    Will Cologuard® test results be delayed due to COVID-19?

    No, Typically, once the sample arrives at the laboratory it takes up to 2 weeks for the laboratory to test the sample and report the result back to the ordering prescriber. Exact Sciences Laboratories is fully operational and no delays to patient testing are anticipated at this time.

    Please note that other issues, such as the need for the laboratory to confirm patient information, may delay a patient’s results.

    If a patient might have COVID-19, should they collect their stool sample and send it back?

    If a patient has symptoms of COVID-19, then it is important to address those acute issues first. If a patient has gastrointestinal symptoms such as acute diarrhea or blood in the stool, then they should wait until their symptoms have resolved before collecting a stool sample.1

    If a patient might have COVID-19 but has already collected a sample, the Cologuard® collection kit may still be sent in as long as there has not been any diarrhea or blood in the stool.1

    Reference: 1. Cologuard® Patient Guide. Madison, WI: Exact Sciences Corporation.

    If a patient might have COVID-19, will handling their Cologuard® collection kit or stool sample transmit the virus?

    There should be no direct contact with the stool sample during the entire collection process, including scraping it for hemoglobin testing.1 COVID-19 concerns do not change this. Before and after stool sample collection, patients should practice safe hygienic measures by washing their hands with soap and water for 20 seconds.2

    The Centers for Disease Control and Prevention has stated that while the coronavirus can survive for a short period of time on some surfaces, it is unlikely to be spread from mail, products, or packaging.3

    Like Exact Sciences, UPS® is closely monitoring the situation. They have plans to maintain their operations while also ensuring the health and well-being of their employees. They have hygiene practices in place, in line with suggestions from agencies such as the World Health Organization.4

    References: 1. Cologuard® Patient Guide. Exact Sciences Corporation. Madison, WI. 2. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): how to protect yourself & others. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed February 17, 2021. 3. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): frequently asked questions. https://www.cdc.gov/coronavirus/2019-ncov/faq.html#anchor_1584386553767. Accessed February 17, 2021. 4. United Parcel Service of America. How UPS is responding to the coronavirus. Frequently asked questions about the coronavirus. https://www.ups.com/us/en/about/news/important-updates.page. Accessed February 17, 2021.

    Should patients take any additional precautions while they are collecting their stool sample?

    No. There should be no direct contact with the stool sample during the entire collection process, including scraping it for hemoglobin testing.1 COVID-19 concerns do not change this. Before and after stool sample collection, patients should practice safe hygienic measures by washing their hands with soap and water for 20 seconds.2

    Collecting a stool sample for the Cologuard® collection kit does not increase the risk of infection transmission over normal defecation, because there is no need for anyone else in the home to handle the stool sample.

    References: 1. Cologuard® Patient Guide. Madison, WI: Exact Sciences Corporation. 2. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): how to protect yourself & others. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed August 14, 2020.

    If a patient’s Cologuard® test is positive, would there be a change in follow-up recommendations?

    No. A positive Cologuard result is not a diagnosis of cancer. However, a positive Cologuard result is associated with an increased chance for colorectal cancer or for advanced precancer.1 Therefore, if a patient has a positive Cologuard result, they should get a follow-up colonoscopy as soon as possible.2 Please be aware that during the COVID-19 pandemic, colonoscopy availability may be limited in many areas. It will be important to work with your endoscopy colleagues to determine a suitable plan for completing a follow-up colonoscopy. If a delay in follow-up colonoscopy evaluation could cause undue anxiety for any of your patients, you may wish to discuss the pros and cons of screening for colorectal cancer with them at this time.

    Additional information on a positive Cologuard test

    References: 1. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297. 2. Cologuard® Physician Brochure. Madison, WI: Exact Sciences Corporation.

    Should I be concerned if a patient with a positive Cologuard® result can’t get a follow-up colonoscopy right away?

    Positive Cologuard results are associated with an increased chance for colorectal cancer or for advanced precancer.1 Therefore, if a patient has a positive Cologuard result, they should get a follow-up colonoscopy.2

    Under normal circumstances, a follow-up colonoscopy within 3 months of a positive stool test has been recommended.3 However, because different parts of the country are affected in different ways, the recommendation may differ based on individual areas of the country. In the beginning of the COVID-19 pandemic, the major GI societies (AASLD, ACG, AGA, ASGE) advised that, for most asymptomatic patients with either a positive Cologuard or FIT test, “colonoscopy should be considered non-urgent and can be delayed by at least 4-6 weeks and reassessed.”4 The AGA and DHPA have since developed joint guidance for resumption of elective endoscopic procedures detailing safety precautions for staff and patients. If a delay in follow-up colonoscopy evaluation could cause undue anxiety for any of your patients, you may wish to discuss the pros and cons of screening for colorectal cancer with them at this time.5

    AASLD=American Association for the Study of Liver Diseases; ACG=American College of Gastroenterology; AGA=American Gastroenterology Association; ASGE=American Society for Gastrointestinal Endoscopy; DHPA=Digestive Health Physician Association.

    References: 1. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297. 2. Cologuard® Physician Brochure. Madison, WI: Exact Sciences Corporation. 3. Doubeni CA, Gabler NB, Wheeler CM, et al. Timely follow-up of positive cancer screening results: a systematic review and recommendations from the PROSPR Consortium. CA Cancer J Clin. 2018;68(3):199-216. 4. American College of Gastroenterology. COVID-19 and GI. Gastroenterology professional society guidance on endoscopic procedures during the COVID-19 pandemic. https://gi.org/media/covid-19-and-gi/. Accessed August 14, 2020. 5. American Gastroenterology Association. AGA/DHPA joint guidance for resumption of elective endoscopy. https://gastro.org/news/aga-dhpa-release-guidance-for-resuming-elective-endoscopy/. Published April 27, 2020. Accessed February 17, 2021.

    Can patients get novel coronavirus (COVID-19) from the Cologuard collection kit?

    Cologuard kit manufacturers have hygiene protocols in place and are following recommendations from the Centers for Disease Control and Prevention (CDC) and the World Health Organization. These protocols help prevent infections from being transmitted to patients. Additionally, Cologuard kits that are returned to the laboratory are not reused. The CDC has stated that the coronavirus has an unlikely risk of spreading from mail or packaging. However, they recommend washing hands with soap and water for 20 seconds or using hand sanitizer with at least 60% alcohol after accepting deliveries.1,2

    References: 1. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): cleaning and disinfection. https://www.cdc.gov/coronavirus/2019-ncov/faq.html#Cleaning-and-Disinfection. Accessed August 14, 2020. 2. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): how to protect yourself & others. https://www.cdc.gov/coronavirus/2019-ncov/faq.html. Accessed August 14, 2020.