Exact Sciences CRC Screening — a complete colorectal cancer screening solution that puts prevention first1-5
SimpleScreen CRC is an FDA-approved screening option for average-risk patients 45+.4* CRC blood tests are recommended by ACS for those who will not complete a preferred screening test.5
Developed and manufactured by Freenome®, LLC
Distributed by Abbott
Sensitivity for CRC
(rate of true positives)
of adults with CRC tested positive4†
Specificity
(rate of true negatives)
of adults without advanced colorectal neoplasia tested negative4‡
Sensitivity for APLs
(rate of true positives)
of adults with APLs tested positive4§
Age- and sex-adjusted to the 2020 US Census population
The ACS recommends colorectal cancer blood tests only for those who decline or will not complete preferred CRC screening tests.5
Patients who choose blood-based tests should be informed about limitations in their ability to5:
- Detect APLs and stage I CRC
- Reduce CRC incidence and mortality
Get the latest CRC news
Stay connected with exclusive monthly access to Cologuard and CRC screening updates
Exact Sciences continues working until more patients complete screening
For patients who will not complete their Cologuard Plus test, the SimpleScreen CRC test can help get more patients screened6
patients adhere to the Cologuard test, helping prevent CRC through early detection2,6
remaining patients can be offered the SimpleScreen CRC test5
With the Exact Sciences ACS-aligned approach, screen the majority of patients with the Cologuard Plus test, and reserve the SimpleScreen CRC test for hard-to-screen patients5,6
Dr Vega has been compensated for sharing his expertise and for acting as a consultant for Exact Sciences.
Understanding coverage for Exact Sciences CRC screening products
Broadly covered across most insurance types
No anticipated out-of-pocket costs for patients 45 and older7**
The ACA and CMS require coverage for follow-up colonoscopies after a positive Cologuard result with no cost sharing8,9
3 years HEDIS® quality credit10
After a negative result, recommended every 3 years for average-risk patients 45+5
and other FDA-approved blood-based CRC screening tests
Covered once every 3 years for Medicare patients11,12
- $0 for the majority of Medicare patients 65+
- Part B will have no out-of-pocket costs
- Part C (Medicare Advantage) may have out-of-pocket costs
Follow-up colonoscopy after a positive result is also covered for Medicare patients11,12
- Part B will have no out-of-pocket costs
- Part C (Medicare Advantage) may have out-of-pocket costs
Commercial members may have out-of-pocket costs
No HEDIS measure credit for any blood-based CRC screening tests13
After a negative result, recommended every 3 years for average-risk patients 45+5
Developed and manufactured by Freenome®, LLC
Distributed by Abbott
It’s easy to get started with blood-based testing offered by Exact Sciences
Choose from 2 simple processes that best fit your practice and your patients:
Provider-managed
(Onsite blood draw with kits stocked)
Order Test
Once ordered, your patient’s blood draw will be completed in provider’s office or central lab
Collect Samples
Blood is drawn and the sample is shipped to the lab for processing
Receive Results
Test results are delivered based on order method
Exact-managed
(Blood draw at home or a partner lab)
Order Test
Once ordered, the provider will inform patient that they will receive a message from Exact Sciences to schedule an appointment
Know the Next Steps
Patient receives email and text prompts to schedule their blood draw at home or at a partner lab
Receive Results
Test results are delivered based on order method
Get started with the Cologuard and SimpleScreen CRC Order Form
The Exact Sciences patient navigation program is there every step of the way to provide:
Welcome
outreach††
Screening
reminders
Bilingual specialists &
translation services
Insurance
assistance
Follow-up
support
3-year repeat
screening
reminders
The SimpleScreen CRC Provider Brochure details the clinical data and complete prescribing information for the SimpleScreen CRC test.
SimpleScreen CRC test FAQs
The SimpleScreen CRC test is a qualitative, in vitro diagnostic test intended to detect molecular signals associated with colorectal cancer. SimpleScreen CRC utilizes circulating cell-free DNA from plasma of peripheral whole blood collected in the SimpleScreen CRC blood collection kit. SimpleScreen CRC is indicated for colorectal cancer screening in adults aged 45 years and older who are at average risk for the disease. Patients with a positive result should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
Precaution
Based on data from clinical studies, SimpleScreen CRC has limited detection (57%) of Stage I 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). One out of 10 patients with a negative SimpleScreen CRC result may have a precancer that would have been detected by a screening colonoscopy.
Contraindications and Limitations
The SimpleScreen CRC test is not indicated for patients who have the following:
- A personal history of colorectal cancer (CRC), advanced precancerous lesions (APL), or other related cancers
- Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) diagnosed with CRC at any age
- Positive result on another CRC screening method within the last six months, or:
- A fecal occult blood test (FOBT) or a 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, Turcot’s/Crail’s syndrome, Cronkhite-Canada syndrome, or Neurofibromatosis
Providers should discuss the most appropriate screening test to use with patients depending on their medical history and individual circumstances. SimpleScreen CRC may produce a false negative or false positive result. A false negative result may occur when the SimpleScreen CRC test does not detect colorectal cancer or advanced precancerous lesions although a colonoscopy would identify either of these findings. A negative result does not guarantee the absence of colorectal cancer or advanced precancerous lesions, and patients should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals. A false positive result may occur when the SimpleScreen CRC test generates a positive result while a colonoscopy will not find colorectal cancer or advanced precancerous lesions.1
- SimpleScreen CRC Provider Brochure. Freenome LLC. Brisbane, CA.
In a clinical study, the SimpleScreen CRC test had an 81% sensitivity in detecting colorectal cancer. The SimpleScreen CRC test had a 90% specificity for advanced cancerous neoplasia. Both numbers were sex- and age-adjusted to the 2020 US Census population. Healthcare providers evaluating colorectal cancer screening blood tests should consider both sensitivity and specificity when selecting screening options.1
- SimpleScreen CRC Provider Brochure. Freenome LLC. Brisbane, CA.
A positive 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 CRC is present.1
- SimpleScreen CRC Provider Brochure. Freenome LLC. Brisbane, CA.
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 precancerous lesions. Patients with a negative test result should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals.1
- SimpleScreen CRC Provider Brochure. Freenome LLC. Brisbane, CA.
Important Information about the SimpleScreen™ CRC test
Intended Use
The SimpleScreen CRC test is a qualitative, in vitro diagnostic test intended to detect molecular signals associated with colorectal cancer. SimpleScreen CRC utilizes circulating cell-free DNA from plasma of peripheral whole blood collected in the SimpleScreen CRC blood collection kit.
SimpleScreen CRC is indicated for colorectal cancer screening in adults aged 45 years and older who are at average risk for the disease. Patients with a positive result should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
Precaution
Based on data from clinical studies, SimpleScreen CRC has limited detection (57%) of Stage I 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). One out of 10 patients with a negative SimpleScreen CRC result may have a precancer that would have been detected by a screening colonoscopy.
Contraindications and Limitations
The SimpleScreen CRC test is not indicated for patients who have the following:
- A personal history of colorectal cancer (CRC), advanced precancerous lesions (APL), or other related cancers
- Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) diagnosed with CRC at any age
- Positive result on another CRC screening method within the last six months, or:
- A fecal occult blood test (FOBT) or a 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, Turcot’s/Crail’s syndrome, Cronkhite-Canada syndrome, or Neurofibromatosis
Providers should discuss the most appropriate screening test to use with patients depending on their medical history and individual circumstances. SimpleScreen CRC may produce a false negative or false positive result. A false negative result may occur when the SimpleScreen CRC test does not detect colorectal cancer or advanced precancerous lesions although a colonoscopy would identify either of these findings. A negative result does not guarantee the absence of colorectal cancer or advanced precancerous lesions, and patients should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals. A false positive result may occur when the SimpleScreen CRC test generates a positive result while a colonoscopy will not find colorectal cancer or advanced precancerous lesions.
Refer to the SimpleScreen CRC Provider Brochure for additional information about the benefits and risks of using the SimpleScreen CRC test.
Rx only. IVD.
Developed and manufactured by Freenome, LLC. Distributed by Abbott.
- The SimpleScreen CRC test was validated in the PREEMPT CRC study, the largest study of its kind. The study showed 79% observed sensitivity for CRC, 92% observed specificity for advanced colorectal neoplasia (ACN), and 13% observed sensitivity for advanced precancerous lesions.4
- A positive result should always be followed up with a colonoscopy.4,5
- Advanced colorectal neoplasia comprised colorectal cancer and advanced precancerous lesions.4
- Adenoma, including with carcinoma in situ or high-grade dysplasia of any size, villous growth pattern (≥25%) of any size, and ≥1.0 cm in size, sessile serrated lesion with or without cytological dysplasia ≥1.0 cm, and traditional serrated adenoma of any size.4
- Exact Sciences estimate based on historical patient billing as of August 2025. Exceptions for coverage may apply; only your patients’ insurers can confirm how the Cologuard test would be covered.
- Patients may receive welcome outreach and reminders via automated calls, live calls, mailed instructions, text messages, and emails. Methods of outreach may vary depending on patient.
ACA=Affordable Care Act; ACS=American Cancer Society; APL=advanced precancerous lesions; CLIA=Clinical Laboratory Improvement Amendments; CMS=Centers for Medicare & Medicaid Services; FDA=Food and Drug Administration; FIT=fecal immunochemical test; HEDIS=Healthcare Effectiveness Data and Information Set; mt-sDNA=multi-target stool DNA.