Screening for colon cancer with Cologuard during COVID-19

In light of the developments of COVID-19, we want to proactively provide information to you about screening for colorectal cancer.

Exact Sciences' testing labs remain fully operational. All sites have plans in place to 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 at home, you can use Cologuard during this pandemic, even while staying home to avoid exposure to or spreading the virus. You can ask your regular healthcare provider or an online prescriber if Cologuard is right for you, without an in-office visit. If they prescribe Cologuard for you, the collection kit is sent directly to your home, and UPS can pick it up for you without social interaction.

Below, we answer questions you may have about using Cologuard during the COVID-19 pandemic.   

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

There’s no doubt that the COVID-19 pandemic has disrupted everyday life. Many people are changing their routines, and taking care of themselves in new or different ways. But preventive health and wellness is still very important.

Screening is the first and most important step in finding and preventing colorectal cancer in all adults 45 years of age and older. Here are some facts about colorectal cancer and how it develops.

Colorectal cancer is one of the most preventable, yet least prevented, cancers in the United States today.1 It is the second-leading cause of cancer deaths in both men and women 50 years of age and older,2 yet one in three adults 50 and older is still not getting screened as recommended.3

Colorectal cancer grows slowly, generally starting from small, non-cancerous polyps in the colon or rectum. While polyps are common and typically don’t cause symptoms, some are dangerous and can turn into cancer over time. If polyps are detected through screening and removed early, the chance of developing cancer can be reduced dramatically.4 If early-stage cancer is detected through screening, treatment is more likely to be successful.2 Therefore, regular screening has the potential to save lives.5

Non-invasive screening options like Cologuard® can be used without an in-office visit to help identify average-risk patients who may currently have cancer or pre-cancer.5 Knowing their patient's screening result helps healthcare providers prioritize follow-up care.

A positive Cologuard result, which fewer patients will receive than a negative result, means you have an increased chance of having colorectal cancer or pre-cancer.5 You should have a follow-up colonoscopy as soon as possible in your area. You do not necessarily have cancer, because false positives can occur.

A negative Cologuard result, which most patients will receive, means you have a very low chance of having colorectal cancer or pre-cancer,5 and you do not need further follow-up at this time. However, false negatives can also occur. You should get screened again in the future.

Whether you receive a positive or negative Cologuard result, talk to your healthcare provider about next steps. For any other questions about Cologuard, please call the Exact Sciences Laboratories Customer Care Center at 1-844-870-8870.

1. Itzkowitz SH. Incremental advances in excremental cancer detection tests. J Natl Cancer Inst. 2009:101(18): 1225-1227. 2. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70(1):7-30. 3. White A, Thompson TD, White MC, et al. Cancer screening test use – United States, 2015. MMWR Morbid Mortal Wkly Rep. 2017;66(8):201-206. 4. American Cancer Society. Cancer Facts & Figures 2020. Atlanta: American Cancer Society; 2020. 5. Cologuard Patient Brochure. Exact Sciences Corporation. Madison, WI

Understanding your Cologuard result

If you receive a positive Cologuard® result, you may be concerned and anxious about whether you have colorectal cancer, and what you should do next. Here is more information that you can review and discuss with your healthcare provider.

A positive result means that Cologuard detected abnormal DNA and/or blood in your stool, which could be caused by colorectal cancer or pre-cancer. You should have a follow-up colonoscopy as soon as possible. However, you do not necessarily have cancer, because false positives can occur.1

  • In a large study of Cologuard among 10,000 average-risk patients ages 50 and older, 16% of the patients received a positive result.2
  • Among the 16% of patients with positive results, 55% had some type of finding during their follow-up colonoscopy: 4% had cancer, 20% had advanced pre-cancer, and 31% had non-advanced pre-cancer.2
  • Also among the 16% of patients with positive results, 45% had no cancer or pre-cancer.2
  • Remember, any positive result should be followed by colonoscopy as soon as possible.

A negative result means that Cologuard did not detect abnormal DNA and/or blood in your stool. You do not need follow-up care at this time. However, false negatives can also occur.

  • In the same large study of Cologuard among 10,000 average-risk patients ages 50 and older, 84% of patients received a negative result.2
  • Among the 84% of patients with negative results, 99.94% did not have colorectal cancer.2
  • Also among the 84% of patients with negative results, 0.06% were diagnosed with cancer through colonoscopy, which was required for all patients in this study.
  • Any negative result should be followed with routine screening again in the future.

Based on this large study, Cologuard is considered an effective way to identify patients who need follow-up colonoscopy. Patients with positive results do not necessarily have cancer,1 but they should be prioritized for follow-up colonoscopy. Patients with negative results can be reassured that they are highly unlikely to have colorectal cancer,2 and they do not need follow-up care at this time.

 

Receiving a positive Cologuard result during COVID-19

Under normal circumstances, patients with positive results should have a follow-up colonoscopy as soon as possible.

However, during the COVID-19 pandemic, it might not be possible to have a colonoscopy as quickly as usual in your area. Because of this, several leading groups of experts in gastroenterology, whose members perform colonoscopies, have recommended that most patients with a positive screening result from Cologuard or another stool test who have no other symptoms could consider colonoscopy to be non-urgent, and wait 4-6 weeks to reassess the timing with their healthcare provider.3 More recently, some leading gastroenterology associations are recommending how to safely resume elective colonoscopies.4 Talk to your provider about your needs and their recommendation.

If the thought of having a delay in follow-up colonoscopy causes you anxiety, you should talk to your healthcare provider about the pros and cons of screening for colorectal cancer at this time.

For any other questions about Cologuard, please call the Exact Sciences Laboratories Customer Care Center at 1-844-870-8870.

1. Cologuard Patient Brochure. Exact Sciences Corporation. Madison, WI. 2. 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. 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 March 31, 2020. 4. American Gastroenterological Association. AGA/DHPA joint guidance for resumption of elective endoscopy. Published April 27, 2020. https://gastro.org/news/aga-dhpa-release-guidance-for-resuming-elective-endoscopy/. Accessed June 23, 2020.

  • Is the Cologuard laboratory still open during the COVID-19 pandemic?

    Yes, our testing labs are open and our Customer Care teams are available 24/7. Plans are in place to ensure continuity of service for patients during this unprecedented time, following all safety procedures and practices. Our lab is still processing all samples that we receive and delivering results to providers within our normal two-week time. If you have any questions, including how to complete your Cologuard screening or how to schedule an at-home pick-up, please call any time at 1-844-870-8870. We’re here to help.

  • Will UPS still pick up packages from peoples homes?

    At this time, UPS has maintained delivery services except where limited by government restrictions, and Cologuard shipments have not been affected.

    You can still schedule a pickup (or we can schedule it for you if you call our Customer Care team at 1-844-870-8870), and UPS will deliver your sample to us.

    Like our team, 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.1

    1. UPS. 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 March 25, 2020.

  • Can I get COVID-19 from using the Cologuard kit?

    Cologuard collection kits are manufactured in regulated facilities that have hygiene protocols in place and are following recommendations from the Centers for Disease Control and Prevention (CDC) and World Health Organization.1,2 These protocols prevent infections from being transmitted to patients.  

    The CDC website states, "In general, because of poor survivability of these coronaviruses on surfaces, there is likely very low risk of spread from products or packaging that are shipped over a period of days or weeks at ambient temperatures. Coronaviruses are generally thought to be spread most often by respiratory droplets."1 

    1. CDC. Coronavirus Disease 2019 (COVID-19). Frequently asked questions. https://www.cdc.gov/coronavirus/2019-ncov/faq.html#anchor_1584386553767 Accessed March 23, 2020. 2. WHO. Q&A on coronaviruses (COVID-19). https://www.who.int/news-room/q-a-detail/q-a-coronaviruses. Accessed April 10, 2020.

  • Will my Cologuard test result be delayed due to the COVID-19 pandemic (COVID-19)?

    No. Our lab is still processing all samples that we receive and delivering results to providers within our normal two-week time, as long as the sample we receive back includes all required information like your name, birthdate, and date of collection.

    If you have any questions, including how to complete your Cologuard screening or how to schedule an at-home pick-up, please call any time at 1-844-870-8870. We’re here to help.

  • If I have COVID-19 or have been exposed, should I still send my sample back?

    If you think you have COVID-19, it’s important that you get better. Connect with your healthcare provider regarding the symptoms you’re experiencing, and ask them if this is the right time for you to screen for colorectal cancer.

    However, if you still want to get screened, you can still collect and send in a sample for Cologuard as long as you are not experiencing diarrhea or blood in your stool1 due to your illness. As always, you should practice good hygiene by washing your hands with soap and water for 20 seconds before and after you collect your sample.2

    1. Cologuard Patient Brochure. Exact Sciences Corporation. Madison, WI. 2. CDC. Coronavirus Disease 2019 (COVID-19). How to protect yourself. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed March 31, 2020.

  • Will handling my Cologuard collection kit or sample get others sick?

    The World Health Organization (WHO) and CDC have stated that there is a low likelihood of the COVID-19 virus contaminating cardboard or other shipping containers.1,2 UPS is providing their employees with advice on how to help prevent exposure.3  Also, our team members who process Cologuard samples always follow safety procedures and practices to protect themselves, from COVID-19 or any other infectious disease.

    As always, you should not have direct contact with your stool sample during the collection process, even when you scrape it with the small white tube used for hemoglobin (blood) testing.4  Also, you should practice good hygiene by washing your hands with soap and water for 20 seconds before and after you collect your sample.5

    1. WHO. Q&A on coronaviruses (COVID-19). https://www.who.int/news-room/q-a-detail/q-a-coronaviruses. Accessed April 10, 2020. 2. CDC. Coronavirus Disease 2019 (COVID-19). Frequently asked questions. https://www.cdc.gov/coronavirus/2019-ncov/faq.html#anchor_1584386553767. Accessed March 23, 2020. 3. UPS. 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 March 25, 2020. 4. Cologuard Patient Brochure. Exact Sciences Corporation. Madison, WI. 5. CDC. Coronavirus Disease 2019 (COVID-19). How to protect yourself. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed March 31, 2020.

  • Are any additional precautions recommended when I collect my stool sample?

    No. You can still follow the instructions that come with the Cologuard collection kit as usual. As always, there is no need for you or anyone else in your home to have direct contact with your stool sample during the collection process, even when you scrape it with the small white tube used for hemoglobin (blood) testing.1  Also, you should practice good hygiene by washing your hands with soap and water for 20 seconds before and after you collect your sample.2

    1. Cologuard Patient Brochure. Exact Sciences Corporation. Madison, WI. 2. CDC. Coronavirus Disease 2019 (COVID-19). How to protect yourself. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed March 31, 2020.

  • If my Cologuard result is positive, is there a change in follow-up recommendations?

    No. Patients with a positive Cologuard result should have a follow-up colonoscopy1 due to the increased chance for colorectal cancer or precancer,2 and that should take place as soon as possible. 

    However, during the COVID-19 pandemic, it might not be possible to have a colonoscopy right away in your area. Because of this, several leading groups of experts in gastroenterology, whose members perform colonoscopies, have recommended that most patients with a positive screening result from Cologuard or another stool test who had no other symptoms could consider colonoscopy to be non-urgent, and wait 4-6 weeks to reassess the timing with their healthcare provider.3 More recently, some leading gastroenterology associations are recommending how to safely resume elective colonoscopies.4 Talk to your provider about your needs and their recommendation. 

    If the thought of having a delay in follow-up colonoscopy causes you anxiety, you may want to talk to your healthcare provider about the pros and cons of screening for colorectal cancer at this time.

    1. Cologuard Physician Brochure. Exact Sciences Corporation. Madison, WI. 2. 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. 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 March 31, 2020. 4. American Gastroenterological Association. AGA/DHPA joint guidance for resumption of elective endoscopy.  Published April 27, 2020. https://gastro.org/news/aga-dhpa-release-guidance-for-resuming-elective-endoscopy/. Accessed June 23, 2020.

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