Cologuard®: A decade of impact

The idea for a test | Late 1990s and early 2000s

Exact Sciences works to develop a groundbreaking screening test that would screen patients’ stool for abnormal DNA suggesting the presence of colorectal cancer. Screening is critical for detecting colorectal cancer in its early stages, when it’s more treatable.^1,2  

Steven Itzkowitz, M.D.
Gastroenterologist at Mount Sinai in New York City who became a publication author for Exact Sciences’ DeeP-C pivotal trial
“Few people ever thought that you could develop a stool test based on DNA, because there’s zillions of bacteria in the stool. The amount of human DNA compared to bacterial DNA is something like one in 100,000. And then among the human DNA, the fraction that’s abnormal and indicative of a polyp or a cancer is less than 1% of that. So you’re not just looking for a needle in a haystack — you’re looking for the head of the needle.  
 

“It really was revolutionary to think that you could develop a stool test based on abnormal human DNA. But after I got involved with Exact Sciences and saw their data in the early meetings, the feeling in the room was, ‘Wow, this just might work. It could be the beginning of a new era.’”
 
Tom Imperiale, M.D. 
Gastroenterologist at Indiana University who became the principal investigator for two pivotal trials of the Cologuard test: DeeP-C and BLUE-C 
“I remember I was at DDW (the annual Digestive Disease Week® meeting of health care professionals) circa 1998, and I asked one of my colleagues where they were going. They said, ‘We’re going into this meeting to learn more about identifying mutations in stool that may help identify colon cancer.’ And I said, ‘Oh, I want to hear more about this.’” 
  
Bryan LaClaire
Senior Screening Solutions Specialist with Exact Sciences since 2015 
“I was not with Exact Sciences yet, but I heard about the Cologuard test from one of my doctors I was calling on as a pharmaceutical rep. The doctor shared with me that this test is going to revolutionize colon cancer screening, and I should find that company and go work for them. After doing my own research, it was my goal to work for Exact Sciences.” 
 

Proving the science | 2011-2014 

Exact Sciences launches the ambitious DeeP-C pivotal trial for its multitarget stool DNA test, which would later be named Cologuard. The young company pulls together, determined to bring an innovative screening solution to patients and health care professionals.  
 
Theran Myers
Senior Director, Process Development and Automation, with Exact Sciences since 2012  
“Everyone did everything in the early days. I remember being a part of collection kit builds — we sealed the FIT tube foil one at a time — and moving the clinical lab multiple times as we worked to complete DeeP-C, including adding a second shift.” 
 
Lorie Madsen
IT Application Architect with Exact Sciences since 2010 
“Back then, we used folders and interoffice envelopes, and I would walk around to people’s desks to distribute them. I would see the DeeP-C map — it was a 6-foot-wide poster that was magnetic and showed the United States. Every time a new site would get enrolled, they would put up a little magnet where that site was located. So as an employee, you could watch that whole picture come together as more and more places were trying out the test.” 
 
Nada Mlinarevich
Senior Director, Thought Leader Engagement, with Exact Sciences since 2010  
“We completed DeeP-C months earlier than what was forecasted. Everyone, including our advisors, said, ‘You guys can’t do it. It’s not possible.’ Well, we did it.” 
 
Rob Fitzgerald
Strategic Account Manager, with Exact Sciences since 2014 
“In the beginning, we couldn’t say a product name, so we promoted screening instead. That wasn’t always the easiest messaging for the sales team, but no matter the challenge, we always stayed true to our mission of helping eradicate cancer. A patient-first mindset has been there since day one.” 

Want more history? Watch a new documentary about the Cologuard test. 

The early days of testing | 2014-2016 

The U.S. Food and Drug Administration (FDA) approves the Cologuard test on Aug. 11, 2014. Exact Sciences begins the work of inspiring patients to take life-changing action for their health.  
 
Alison Nielsen
Associate Director, Gap Closure Program, first joined Exact Sciences in 2009 and since returned 
“I will never forget when we received FDA approval. To know the product that we had been working on for so many years was coming to fruition and going to be able to be marketed across the country — it was an incredible moment. We raced to get materials out to our field sales team, who were eagerly waiting to be able to sell.” 
 
Peter Wood
Vice President, Screening Portfolio Strategy, with Exact Sciences since 2012 
“The day we got approval, there was a team ready to start rolling, so we stayed late getting everything ready and preparing for the days to follow. I remember the first order and days we celebrated getting more than 10 orders.” 
 
Matt Homstad
Clinical Laboratory Quality Control Lead, with Exact Sciences since 2015  
“I can remember how much our all-team meetings grew from everyone fitting in the small lunchroom to hundreds of people and not having enough room. We also began to take over the entire building, including turning that lunchroom into more lab space. I will never forget getting over 100 kits for the first time. That milestone really seemed to raise morale and create a feeling of success — that we were truly making a difference in patients’ lives.” 
 

Growth and scale | 2017-2024 

As Exact Sciences continues to grow, the company helps create more and more opportunities for patients to be screened for colorectal cancer using the Cologuard test. 
 
Kyle Stacey
Senior Vice President, Finance, with Exact Sciences since 2009  
“I remember the first time we experimented with TV advertisements. It was exciting to see we had unlocked a new, great way to get the word out about the Cologuard test and colon cancer screening. Many of my relatives had never been screened for colon cancer and probably wouldn’t have without Cologuard. I’m glad they got their first test and that our compliance engine helped them stay on track with screening over the years.” 
 
DeVante Sago
Corporate Security Supervisor with Exact Sciences since 2016 
“The (U.S. Preventive Services Task Force) screening age change for people 45 and older was exciting. The news came on the heels of the untimely colorectal cancer death of (a high-profile actor in his 40s). But this change was met with so much optimism, knowing that the work that we do can potentially help so many people by getting them screened earlier and giving them a fighting chance for care.” 
 
Steve Knapp
Director, Manufacturing Sciences and Quality Control, with Exact Sciences since 2017 
“I remember the teamwork and accountability shown by the entire company to keep the Cologuard test available through the pandemic. There were significant, frequent supply-chain interruptions that kept many teams working constantly to implement mitigations that had been previously planned or developed quickly. This work kept Cologuard reagents fully stocked throughout the pandemic in the midst of many challenges, all while implementing the COVID-19 test in parallel to support the Exact Sciences team and the broader community.”    
Emmy Staples
Pipeline Team Lead Director with Exact Sciences since 2014 
“Ten years ago, I was hired to establish the service and service training departments and was the only lab engineer at Exact Sciences at the time. I remember the daunting sight of hundreds of boxed laboratory instruments stacked along the entire 50-yard length of the lab hallway waiting for me to install. As Cologuard throughput has grown, so have the service and training teams. Today, they span the globe and are composed of hundreds of exceptional team members dedicated to serving our patients by keeping our platforms running day and night. The laboratory service team has risen to meet ceaseless demands and kept our promise to deliver world-class patient care. I am honored and humbled to have helped in the growth of these amazing departments.” 
 
Marilyn Olson, Ph.D.
Vice President, Pipeline Product Development, with Exact Sciences since 2017 
“I started working on the first version BLUE-C protocol in 2019 to evaluate the performance of what will be the next generation of the Cologuard test. The R&D team spent years developing and optimizing and validating the test, and it resulted in a successful clinical validation study that was recognized in a top-tier, peer-reviewed journal. Yes, it was satisfying. But we hear these patient stories, and I think we all feel it, knowing that what we developed actually can help detect cancer and precancer in a person and potentially change their life — that’s pretty impactful.” 
 

Bold past, bright future | 2024 and beyond 

As Exact Sciences marks the 10-year anniversary of the Cologuard test and looks forward to introducing the next generation of the test, the colorectal cancer community reflects on a decade of patient impact. 
 
Anas Daghestani, M.D. 
CEO, Austin Regional Clinic 
“We take a population health approach that is both proactive and personal. Twice a year, using our data for the 700,000 patients we take care of, we focus our attention on those who are due or overdue for a colon cancer screening. We communicate using the patient’s preferred method — by letter, patient portal message, or text — and educate them on the importance of completing their screening. Offering Cologuard as an option, we coordinate with Exact Sciences to send the kit to the homes of all interested patients. Our patients appreciate being able to complete the test at their convenience. In 2023, we completed over 6,000 tests, and we saw about a 10% to 15% improvement in our colon cancer screening rates. We are confident our efforts lead to the outcome we set out to achieve: improving early detection and prevention of colon cancer.” 
 
Michael Sapienza 
CEO, Colorectal Cancer Alliance 
“No. 1, Exact Sciences brought noninvasive tests to the forefront of America’s minds. No. 2, they also played a big part in helping the whole colorectal cancer community, including the Alliance, lower the screening age to 45 and then reach that 45-to-49 age group. And No. 3, from a health equity perspective, they have been one of the strongest voices in making sure that Cologuard is a test that is not just for people that can afford it, but for everyone.  
 
“We continue to see the value in noninvasive testing to increase screening rates. For those in the 45-to-49 age group, they’re busy, they have kids, they don’t have time to take off of work, and the Cologuard test can reduce the barriers for people in that age group. The same is true for people that have hourly jobs, single parents, people who live in rural communities, etc. Cologuard has been a really great test to make sure that they have no excuses and no barriers to getting screened.” 
 
Nina 
Colorectal cancer survivor who screened with the Cologuard test 
“Seven years ago, I tested positive with Cologuard, and it put me on a completely different path. I don’t take life for granted anymore. My husband and I have been traveling as often as we possibly can. I have gotten to see my closest friend’s daughter graduate from dental school, and my best friend became a grandmother. All of these things I got to experience because of the path Cologuard put me on. I absolutely had no idea anything was wrong with me. Forever grateful for what that test was able to do for me. Life is good.”

Want more history? Watch a new documentary about the Cologuard test. 



References and footnotes  

Each story reflects an individual’s experience. Not every person will have the same treatment, experience, outcome, or result. The Cologuard test is prescribed by your health care provider. Talk to your health care provider about available screening options and whether the Cologuard test may be right for you. There are potential risks associated with the Cologuard test and it may not be appropriate for all patients. For more information about the risks, talk to your health care provider or visit Cologuard.com for more information. 
 
1. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74:12-49. 
  
2. Itzkowitz SH. Incremental advances in excremental cancer detection tests. J Natl Cancer Inst. 2009;101(18):1225-1227. doi:10.1093/jnci/djp273