SimpleScreen CRC FAQs
SimpleScreen CRC is a prescription only noninvasive blood test. It works by detecting signals associated with colorectal cancer through a standard blood draw that can be collected at any routine patient visit.
SimpleScreen CRC has limited detection of precancer and stage 1 colorectal cancer. The American Cancer Society guideline advises that blood-based tests should only be recommended to individuals who decline or have not completed one of the preferred colorectal cancer screening tests.¹ No bowel preparation or dietary restrictions are required.
1ACS. American Cancer Society Guideline for Colorectal Cancer Screening. Updated May 27, 2026. Accessed September 2, 2026. https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/acs-recommendations.html.Although blood tests can be a helpful way to screen for colon cancer, the American Cancer Society’s guideline directly states:
"Blood-based screening tests are not preferred screening options at this time. You should only use a blood-based test if you’re not willing to get a stool-based test or a visual exam. You’ll need to get a follow-up colonoscopy if the blood-based test is positive. These tests aren’t as good at detecting precancerous growths, which may limit their potential to prevent colorectal cancer.” 1
Doctor discussion guideNo, Cologuard Plus is a noninvasive, stool-based screening test. SimpleScreen CRC is a blood-based screening test. Both are intended for adults 45 and older at average risk for colon cancer, but they are different tests.
SimpleScreen CRC is a blood-based test that uses a standard blood draw to detect DNA signals associated with colon cancer. Cologuard Plus is a stool-based DNA test that requires you to collect a stool sample at home and ship it back to the lab to receive your test result. Both are noninvasive, FDA-approved, and intended for adults 45 and older at average risk for colon cancer.
The American Cancer Society’s guideline directly states:
“Blood-based screening tests are not preferred screening options at this time. You should only use a blood-based test if you’re not willing to get a stool-based test or a visual exam. You’ll need to get a follow-up colonoscopy if the blood-based test is positive. These tests aren’t as good at detecting precancerous growths, which may limit their potential to prevent colorectal cancer.” 1
Talk with your doctor about which option fits your family and screening history, including preferences.
1 ACS. American Cancer Society Guideline for Colorectal Cancer Screening. Updated May 27, 2026. Accessed September 2, 2026. https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/acs-recommendations.html.No, a blood test does not replace a diagnostic or surveillance colonoscopy for people at higher risk. A positive SimpleScreen CRC result should be followed by a colonoscopy.
SimpleScreen CRC tests your blood for cancer signals, with results that have shown:
- 81% cancer detection: Flags 81 out of 100 colorectal cancers, helping with detection and treatment.1
- 90% specificity: Yields a negative result for 9 out of 10 people who don't have cancer or advanced precancerous lesions.1
1SimpleScreen CRC Provider Brochure. Freenome LLC. Brisbane, CA.
Based on data from clinical studies, SimpleScreen CRC has limited detection of stage 1 (57%) colorectal cancer (64% when U.S. 2020 Census age-sex adjusted) and does not detect 87% of advanced precancerous lesions (86% when U.S. 2020 Census age-sex adjusted).1
1 out of 10 patients with a negative SimpleScreen CRC result may have a precancer that would have been detected by a colonoscopy.1
1SimpleScreen CRC Provider Brochure. Freenome LLC. Brisbane, CASimpleScreen CRC is a noninvasive option for people who:
- Are 45 years old or older
- Have an average risk for colon cancer
- Have declined or did not complete an American Cancer Society preferred colon cancer screening method, such as a stool-based test or a colonoscopy
Talk to your doctor about other noninvasive screening options, like the Cologuard Plus test, to see which one works best for your needs and lifestyle.
SimpleScreen CRC is NOT indicated for use for patients that have the following:
- A personal history of colorectal cancer (CRC), advanced precancerous lesions (APLs), or other related cancers
- A family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) diagnosed with CRC at any age
- A positive result on another CRC screening method within the last six months, or:
- A fecal occult blood test (FOBT) or fecal immunochemical test (FIT) within the last 12 months
- A FIT-DNA test within the last 36 months
- Personal history of any of the following high-risk conditions for CRC:
- Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn’s disease
- Relevant hereditary cancer syndromes including but not limited to: hereditary non-polyposis colorectal cancer syndrome (HNPCC) or Lynch syndrome, familial adenomatous polyposis (FAP or Gardner’s), Familial Hyperplastic Polyposis, Peutz-Jeghers syndrome, MUTYH-associated polyposis (MAP), Cowden’s syndrome, Juvenile polyposis syndrome, serrated polyposis syndrome, and Turcot’s/Crail’s syndrome, Cronkhite-Canada syndrome, or Neurofibromatosis
Request a SimpleScreen CRC blood test from your doctor at your next checkup. They can order one for you and help schedule your blood draw. If they can’t perform it onsite, we can ship a kit to you. Take it to a local lab or use during a scheduled home visit with a mobile phlebotomist. Please keep the kit unopened until your appointment. You’ll receive your test result in about 2 weeks. Use our discussion guide to start a conversation with your doctor.
Yes, your doctor or primary care provider will need to order a blood test for you. It’s important to discuss with them all the other ways to screen for colon cancer to determine which method is right based on your personal and family history.
No, your doctor or primary care provider will need to order a SimpleScreen CRC blood test for you.
Follow the progress of your test and view your result by signing up for the Exact Sciences patient portal or MyChart.
Our Customer Care team is available every day from 6 a.m. to 10 p.m. CT to answer your SimpleScreen CRC questions. Just give us a call at +1 844-870-8870.
Prep and process
SimpleScreen CRC is performed through a standard blood draw. Your doctor or primary care provider will need to order the test for you.
After your doctor has ordered a test for you, there are 3 places where you can get blood drawn:
- In-clinic or a hospital: Complete your blood draw during a routine checkup or hospital visit.
- A lab: Set up an appointment at a lab that’s near or convenient for you.
- Mobile phlebotomy: Depending on where you live, you can choose to have a phlebotomist come to your home to do a blood draw.
Just like the Cologuard Plus® test, there’s no prep needed for SimpleScreen CRC.
Learn about cost and coverageIf you are not able to have your blood drawn within your clinic or healthcare system, you can have your blood drawn using Exact Sciences-managed services. Exact Sciences has a broad phlebotomy network across the U.S. Exact Sciences-managed blood collection options and availability vary by zip code and are not guaranteed. To learn more, call us at +1 844-870-8870, every day, 6 a.m. to 10 p.m. CT.
Test results and next steps
Your test result will be available in about 2 weeks after the lab receives your blood sample.
Your doctor or primary care provider will receive a copy of your result. You’ll also be able to access your SimpleScreen test result by logging into your Exact Sciences patient account.
A negative result indicates the test did not detect a signal associated with colorectal cancer or advanced precancerous lesions. A negative test result does not guarantee absence of colorectal cancer or advanced precancerous lesions.
A "no result" means your test could not be completed. The lab could not process your sample due to a technical issue, such as a shipping error, failure to pass quality control tests, or insufficient blood. It is not a colon cancer diagnosis.
Contact your doctor or primary care provider right away to schedule another blood draw. Consider asking if other noninvasive screening options, such as the Cologuard Plus® test, will work for you. In a study that included a subset of nearly 19,000 average-risk patients aged 45-86, Cologuard Plus detected 95% of Stage I to IV colon cancers. In a subset of 20 adults aged 45-59, Cologuard Plus detected 100% of all colon cancers.1
Request Cologuard PlusA positive SimpleScreen CRC result indicates a signal was detected that may suggest the presence of colorectal cancer or advanced precancerous lesions. A colonoscopy evaluation is necessary to determine whether colon cancer is present. Talk to your doctor or provider so they can schedule a colonoscopy for further testing.
Yes. A false positive result occurs when the test produces a positive result even though a colonoscopy will not find colon cancer or advanced precancer lesions (APLs). SimpleScreen CRC has a false-positive rate of 10%. This means 1 out of 10 people who do not have colorectal cancer or advanced precancerous lesions may receive a positive result.1 A positive result should be followed by a colonoscopy because there is an increased chance of colon cancer or an advanced precancerous polyp.
1SimpleScreen CRC Provider Brochure. Freenome LLC. Brisbane, CAYes, a false negative result occurs when the test does not detect colon cancer or advanced precancer lesions (APLs), although a colonoscopy would identify either of these findings. SimpleScreen CRC has a false negative rate of 21% for colorectal cancer, meaning 21 of 100 people who have it will have a false negative result.1
1SimpleScreen CRC Provider Brochure. Freenome LLC. Brisbane, CAYes, a positive result requires a follow-up colonoscopy. Your doctor or primary care provider will guide you through your next steps.
Cost and insurance coverage
Coverage and out-of-pocket costs can vary by plan. We recommend checking with your insurance provider to confirm if SimpleScreen CRC is covered and what your out-of-pocket cost may be.
SimpleScreen CRC is covered for Medicare Part B and MedAdvantage plans. Possible out-of-pocket costs may occur, so please check with your insurance provider.
Coverage and out-of-pocket costs for follow-up colonoscopy following a positive screening test result can vary by plan. We recommend checking with your insurance provider to confirm if SimpleScreen CRC is covered and what your out-of-pocket cost may be.
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