FDA approval previews the Cologuard® test’s next chapter

In the 1990s and early 2000s, not enough people were getting screened for colorectal cancer (CRC), a major cause of death in the United States.^1,2 
  
Then, in 2014, Exact Sciences launched the Cologuard test, a noninvasive CRC screening test for people of average risk.  
 
Over the past decade, people have used the Cologuard test more than 17 million times. The test is estimated to have detected hundreds of thousands of instances of cancer and precancer, helping people take life-changing action.³ 
  
Today, after celebrating a decade of impact on millions of lives, the Cologuard test is embarking on a new chapter: the next generation of this groundbreaking screening solution. 
  
In October 2024, the U.S. Food and Drug Administration (FDA) approved Cologuard Plus, the company’s next-generation multi-target stool DNA test. The approval marks a critical step in bringing to market the newest addition to the Cologuard family of tests. Exact Sciences expects the test to be available in 2025. Read the press release. 
 
The newest test in the Cologuard family resulted from 10-plus years of collaborative research with Mayo Clinic and other investigators to identify and validate molecular markers that can differentiate patients with or without CRC or precancers, says Paul Limburg, M.D., chief medical officer for screening at Exact Sciences. 
 
“Our research and development team has shown exceptional creativity and remarkable commitment to ongoing innovation,” Limburg says. “That innovation will accelerate our purpose to help eradicate cancer and create an even higher standard of performance that keeps patient and provider needs at the forefront.” 
 
The BLUE-C clinical validation study demonstrated the accuracy of the Cologuard Plus test. The test is expected to deliver improved detection of cancers and precancers, as well as fewer referrals for unnecessary follow-up colonoscopies resulting from false-positive tests, Limburg says. 
  

Watch a documentary series tracing the history of the Cologuard test. 

  
CRC remains the second leading cause of cancer-related death for men and women in the United States, in part because not enough people get screened.⁴ Screening is critical for detecting early-stage CRC and advanced precancers, when interventions are more effective for treating or preventing the disease, yet an estimated 60 million screening-eligible adults in the U.S. remain unscreened.⁵ 
  
In the decade since its launch, the Cologuard test has moved the needle on CRC screening for people in the U.S. Based on the number of Cologuard tests completed to date, modeling data estimate that the test has: 
  
•  Detected 623,000 instances of cancer and advanced precancerous lesions 

•  Found 80% of cancers at an early stage, reducing the need for intensive treatments 

•  Saved more than $22 billion in health care costs due to pre-cancer and early cancer detection, as compared to no screening^3,6,7 
  
According to data from the Centers for Disease Control and Prevention, use of the Cologuard test is the primary contributor to an increase in CRC screening rates from 63% in 2015 to 72% in 2021 among Americans ages 50 to 75.⁸ In addition, a recent Epic Research study shows that the number of people ages 45 to 49 completing the Cologuard test tripled between 2021 and 2023.⁹ 
 
That impact is poised to grow, Limburg says. 
  
“For the decade that Cologuard has been available, it’s been encouraging to see the increasing number of patients whose colorectal cancer screening needs and preferences have been met with this noninvasive, accessible test,” he says. “With 60 million unscreened or under-screened individuals in the United States, we know that there is still a tremendous need for molecular solutions that can effectively and efficiently meet patients where they are.”  
 
With a new test on the horizon that builds upon a decade of positive impact, “we’re excited by what the Cologuard Plus test can deliver for patients and providers,” Limburg says. 
  
Watch Limburg and others reflect on the Cologuard test’s impact: