New modeling data have been released that describe the projected impact of the first and only multitarget stool DNA test (marketed as Cologuard) on patients, health-care professionals, and the U.S. health-care system since its U.S. Food and Drug Administration (FDA) approval 10 years ago.
About the Test
The test is used for first-line colorectal cancer screening in adults aged 45 years or older who are at average risk for the disease. Over the past 10 years, it has been used to screen for colorectal cancer more than 16 million times. It is included in national colorectal cancer screening guidelines by the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021).
The test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. It looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer; it was shown to effectively detect colorectal cancer and precancer in the pivotal phase III DeeP-C study.
The test is an important tool for closing the gap of 60 million Americans not up to date with screening. According to data from the Centers for Disease Control and Prevention (CDC), use of the test is the primary contributor to the increase in colon cancer screening rates from 63% in 2015 to 72% in 2021 among Americans ages 50 to 75 years. In addition, a new study from EPIC research showed that the number of people aged 45 to 49 years completing screening with the test tripled from 2021 to 2023.
10 Years of Patient Impact
The modeled data projects that over the past 10 years:
- There have been more than 16 million completed screenings with the multitarget stool DNA test, or approximately one every 20 seconds.
- The test detected advanced precancerous lesions—growths that would most likely advance to cancer—in approximately 525,000 people.
- 80% of cancers detected by the test were early-stage cancers.
- 42,000 people were identified with stage I disease.
"Colorectal cancer is the number two cancer killer, 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 Folasade May, MD, PhD, MPhil, Director of Quality in Digestive Diseases at UCLA Health and cofounder and board member of the Association of Black Gastroenterologists and Hepatologists. "With the convenience of a noninvasive use-at-home test and the ability to find more than 90% of cancers as well as many precancers, [The multitarget stool DNA test] is unique among noninvasive tests. That’s why I recommend it as an option to average-risk individuals who prefer to screen with a home-based option."
Improvements in Screening Participation and Health-Care Costs
The strong performance of the test has also positively impacted colorectal cancer screening rates, the economy, and health-care access and costs. The modeled data projected that since the test was introduced:
- More than $22 billion has been saved in health-care costs due to precancer and early cancer detection as compared to no screening.
- The test contributed to 77% of the improvement in colorectal cancer screening rates between 2018 and 2021.
- 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 test as an alternative to colonoscopy in eligible patients has helped save:
- 2.1 million scheduling hours
- 3.5 million nursing hours
- 1.1 million provider hours.
During a time when at-home health and wellness tests were relatively limited, the stool DNA test transformed colorectal cancer screening access. Within a decade, more people were screened for colorectal cancer than ever before because of the 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.
