In 2014, Madison-based Exact Sciences Corp. introduced a product that could revolutionize cancer screening.
Cologuard, a noninvasive, at-home screening test that detects the presence of colon cancer in stool samples, has been used by millions of Americans age 50 and up, a segment of the population that grows every year. The test, covered by many insurance providers, could inspire others that detect other forms of cancer.
“Cologuard is all about removing barriers and making it easier to get screened,” said Kevin Conroy, chief executive officer of Exact Sciences.
Reporter Catherine Jozwik recently interviewed Conroy about the company’s extensive growth, recent partnership with Pfizer Inc. and future goals.
How long did it take to get Cologuard from the conception stage to market?
“Cologuard took shape between 2009 and 2014. When I joined the company as CEO in April 2009, we moved it to Madison and essentially rebooted the entire operation.
“Successful research and development over the next few years culminated in a pivotal, 10,000-patient study published in The New England Journal of Medicine in April 2014, which validated the effectiveness of Cologuard to detect cancer and pre-cancers. From there, we had to get the product approved.
“In August 2014, Cologuard became the first product to take part in the FDA and (Centers for Medicare and Medicaid Services) parallel review pilot program, in which both agencies simultaneously review medical devices. This was huge for us, because it meant we got our product approved, and Medicare insurance coverage for Cologuard, all within a few months.”
How did Exact Sciences gain the financial backing to launch Cologuard?
“When you’re trying to create a new product and improve cancer screening rates, nothing is easy. In April 2009, the country was in the midst of a recession. At the time, we had a market capitalization of $30 million and $30 million cash in the bank. That means investors valued us at $0 – we had a lot of work to do. As a publicly-traded company, we focused our efforts on institutional investors. We outlined our idea, the team and our path forward.
“From there, it was a matter of helping investors understand the size of the colorectal cancer screening problem, and the ability of a new test to truly transform the market.
“Colorectal cancer is the No. 2 cancer killer in the United States, but it is treatable if detected early. It’s estimated that more than 30 million Americans are not current with colorectal cancer screening guidelines, because they are not willing to get a colonoscopy. So, we met with a lot of people, told them about the opportunity to get more people screened for colorectal cancer, and our vision for how a new kind of test could make a real difference. During my time as CEO, we’ve done 4,500 investor meetings, 130 investor presentations and 12 capital raises. From those efforts, we’ve been able to raise $1.8 billion, which gives us the ability to think big and invest in the long-term growth of the company.”
Exact Sciences has experienced massive growth over the past several years, with the company’s annual revenue more than doubling since 2017. What has helped fuel this growth?
“Our growth is driven by demand for Cologuard. At the end of February, we announced we’ve now helped screen 2 million Americans for colorectal cancer – 1 million of those in the last year alone. We’re tremendously honored to have earned the trust of those patients and the nearly 147,000 health care professionals who prescribe Cologuard.
“Also helping drive these numbers is widespread insurance coverage for Cologuard. Today, 94 percent of people who get a Cologuard test have zero out-of-pocket costs because Cologuard is a screening test and is covered by most insurance plans as a preventive benefit. In the last year alone, we’ve added about 80 million Americans whose insurance covers Cologuard.”
What are some long-term goals for the Exact Sciences and Pfizer partnership?
“The partnership is all about getting the life-changing power of Cologuard in front of more doctors, nurses and health care systems. We have a co-promotion agreement with Pfizer.
“Recently, Pfizer extended the agreement to the part of their sales team that calls on OB-GYN offices. For many women, their OB-GYN is the primary care doctor, so we think this could make a huge difference in improving screening rates. I think years from now, people will look back at the Exact Sciences-Pfizer relationship as a turning point in the fight to end colorectal cancer.”
Cologuard uses protein and DNA biomarkers to detect the presence of colorectal cancer. How can these biomarkers be applied to other types of cancer detection?
“We have plans to extend our technology and processes to take on the top 15 deadliest cancers. Our whole goal as a company is to make early detection possible, because we know that cancer is a disease of the DNA and that DNA can be found in the blood.
“For the past seven or eight years, we’ve been working with Mayo Clinic to identify and validate biomarkers across a variety of forms of cancer. We hope to bring those findings to market in the form of new cancer screening tests. When cancer is detected too late, there is often little that can be done to change outcomes. Early detection changes lives. That’s what energizes us and guides Exact Sciences’ development.”
