New Modeling Data Show the Cologuard® Test Has Detected More Than 623,000 Cancers and Precancers Over Past Decade, Saving U.S. Health Care System $22 Billion
Data demonstrate long-term impact of the Cologuard test, a powerful tool for preventing and detecting cancer
The data assessed the far-reaching benefits of the first and only multi-target stool DNA test for patients, their families, and the health care system. Over the past 10 years, the Cologuard test has been used to screen for colorectal cancer (CRC) more than 16 million times.
The Cologuard test is the most effective noninvasive option for CRC screening1 and an important tool for closing the gap of 60 million Americans not up to date with screening.2 According to data from the
“As Exact Sciences marks the 10th anniversary of Cologuard, we reflect on the vital role that it has played in the prevention and early detection of colorectal cancer, making screening more accessible and effective for patients,” said
10 years of patient impact
The modeled data projects that over the past 10 years5*:
- There have been more than 16 million completed screenings with the Cologuard test, or approximately one every 20 seconds.
- The Cologuard test detected 525,000 people with advanced precancerous lesions — growths most likely to advance to cancer.Removal of these growths can help prevent cancer.
- 80% of cancers detected by the Cologuard test were early-stage cancers.
- 42,000 people were identified to have stage I. By detecting cancer earlier, patients are less likely to need chemotherapy or radiation treatment, sparing them and their families that difficult experience.
“Colorectal cancer is the number two cancer killer6, but it doesn’t need to be this way. We have very effective tools to find the precursors to this cancer and also to detect these cancers at earlier, more curable stages,” said Dr.
Improvements in CRC screening participation, health care and the economy
The strong performance of the Cologuard test has also positively impacted CRC screening rates, the economy, health care access and costs. The modeled data projected that since the Cologuard test was introduced5*:
-
More than
$22B has been saved in health care costs due to pre-cancer and early cancer detection as compared to no screening.5,8,9* - The Cologuard test contributed to 77% of the improvement in CRC screening rates between 2018 and 2021.9
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Health care staff were able to reduce hours spent toward screening average risk and asymptomatic people, allowing them to focus on treating people with symptoms and those who are high risk with colonoscopies. The projections show use of the Cologuard test as an alternative to colonoscopy in eligible patients has helped save:
- 2.1 million scheduling hours5,10*
- 3.5 million nursing hours5,10*
- 1.1 million provider hours5,10*
During a time when at-home health and wellness tests were relatively limited, the Cologuard test transformed CRC screening access. Within a decade, more people screened for colorectal cancer than ever before because of the Cologuard test — playing a critical role in addressing the screening gap for average-risk adults that colonoscopies and other tests cannot close alone. Data show that if colonoscopy were the only tool available, it would take more than 10 years to address the backlog.1,5,11
“I was 47 when I screened with Cologuard,” said
*Estimates are based on modeling projections using performance data from the pivotal DeeP-C study
† Dr.
1. Fendrick AM, Fisher DA, Saoud L,
2. Ebner DW, Kisiel JB, Fendrick AM, et al. Estimated Average-Risk Colorectal Cancer Screening-Eligible Population in the US. JAMA Netw Open. 2024;7(3):e245537.
3.
4.
5. Estes C, Dehghani M, Ozbay A, et al. Clinical, social and economic impacts of colorectal cancer screening with the multi-target stool-DNA test: 10-year experience – a simulated study. MedRxiv.orghttps://doi.org/10.1101/2024.08.07.24311643
6. ACS. Cancer facts & figures 2024.
7. 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.
8. Fitch K, Pyenson B, Blumen H, et al. The value of colonoscopic colorectal cancer screening of adults aged 50 to 64.
9. Ebner DW, Finney Rutten LJ, Miller-
10. Horejsi A,
11. Joseph DA, Meester RG,
About the Cologuard test
The Cologuard test is a first-line colorectal cancer screening test for use in adults age 45 or older who are at average risk for the disease. It is included in national colorectal cancer screening guidelines by the
The Cologuard test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. The test looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown to effectively detect colorectal cancer and precancer in the pivotal phase 3 DeeP-C study.3 The Cologuard test is easy to use. It can be completed at home and does not require any time off or special preparation. In the initial 10 years since launch, the Cologuard test was used more than 16 million times.
Important information about the Cologuard test
Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit Cologuard.com. Rx only.
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Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the
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