Ten years ago, Exact Sciences wasn’t a diagnostics powerhouse. The Madison, WI-based test had not yet gained FDA approval for Cologuard, its DNA-based colorectal cancer test. It didn’t have the support of insurers that it now has today. The firm was still very much in the state of transition. MD+DI spoke with Exact Sciences CEO, Kevin Conroy about the company’s past, present, and future.
MDDI: Let’s talk about a little bit about when you took over the helm at Exact Sciences. How did that come about, and what was the company like back then? What was the mood and what direction was the company going in?
Conroy: In 2009, Exact Sciences wanted to reinvent itself. The company was struggling, yet board members believed in the importance of the company’s vision. The next steps for Exact Sciences would be a beginning or an end. When a recruiter reached out to me, I had some doubts given the company’s previous failures. As conversations continued, Maneesh Arora, who went on to became chief operating officer of Exact Sciences, and I traveled to Mayo Clinic in Rochester, Minnesota. There we met with gastroenterologist and researcher, Dr. David Ahlquist. Dr. Ahlquist shared with us recent data showing significant improvements in the ability to detect colorectal cancer in stool. We both left converted. We believed Exact Sciences could help solve a big problem in health care and get more people screened for colon cancer.
MD+DI: How has technology changed since you became CEO at Exact Sciences. What breakthroughs or changes in technology have you seen in cancer detection since then?
Conroy: Through our collaboration with Mayo Clinic, we conduct research into the potential of a blood draw to screen for cancer or cancer recurrence, often referred to as liquid biopsy. Together we have discovered unique biomarkers for 13 of the top 15 cancers and will use these markers to develop liquid biopsy tests. I believe the creation of a sensitive and specific liquid biopsy test will be a significant breakthrough in cancer detection. Through our research collaboration and well-developed commercial capabilities, we are uniquely positioned to play a role in that breakthrough.
The healthcare community now places a growing emphasis on screening and preventive medicine. Health care providers and health economists can agree it is better to catch disease early, when treatment options for diseases like cancer are significantly less invasive and less expensive. It’s a trend Cologuard has been at the forefront of, helping people who may have been reluctant to get screened, and giving health care providers another option for their patients. This year we’re working to make Cologuard available to even more people. The American Cancer Society updated its guidelines last May to recommend that screening start at age 45 for people of average risk for colon cancer. Exact Sciences recently submitted our application to FDA for a label expansion that would allow us to offer Cologuard to people in this age group.
MD+DI: Now from my understanding Exact Sciences had some difficulty when you first started. As a CEO, how were you able to deal with those difficulties and when would you say the company began turning around.
Conroy: Embarking on a collaboration with Mayo Clinic marked a critical moment in the effort to turn around the company. Dr. David Ahlquist had the vision and challenged us to push harder to create a test that truly would help people get screened, by making it more accurate and easier to use. Along with Mayo Clinic, we focused the company on three priorities at the beginning of each year. These priorities made it clear to the entire team what we wanted to accomplish. We would then spend the year fully aligned and working together to achieve those goals. It’s a discipline and practice that’s been incredibly successful for this company, positioning us to lead the industry in earlier detection.
MD+DI: And Mayo Clinic isn’t the high profile partnership that you have. Talk a little bit about the collaboration with Pfizer. Is it expected the partnership will help increase the visibility of Cologuard?
Conroy: Pfizer is a tremendous partner committed to the same cause that we are—to make colorectal cancer screening accessible for everyone. We continue to work closely with Pfizer's team to enhance creative messaging, optimize the mix of advertisements and effectively invest to raise Cologuard awareness. We expect the partnership along with the efforts of the Exact Sciences field force to generate increasing demand for Cologuard and we stand ready to handle that demand. We will open our second state-of-the-art laboratory this summer. It will expand annual capacity from 3 million at our current lab to 7 million with two labs running.
MD+DI: I understand the company has been busy on the M&A trail lately. Talk about the benefits of acquiring Biomatrica.
Conroy: Our pipeline focuses on the research and development of new, minimally invasive tests to detect cancer earlier. To be successful, we need to have the right team backed by the highest-quality science, data and materials. Dr. Graham Lidgard, our chief science officer, set out to find the best tubes for liquid biopsy—the technology that would best preserve the quality of samples to ensure reliable results. In Biomatrica, Graham found the chemistry to preserve biomarkers at the molecular and cellular level in blood and saliva that is unmatched in the industry. Beyond being a part of our pipeline efforts, Biomatrica continues to serve a wide range of customers—from clinical diagnostics and consumer genomics to drug development, biobanking/forensics, and genomic research institutions. Exact Sciences and Biomatrica fit together well, and the acquisition advances our goal of detecting cancer earlier.
MD+DI: As a CEO, what keeps you up at night? What are you constantly thinking about in terms of the business and healthcare environment?
Conroy: I advise my team to search for big health care problems and look for ways to solve them. Ten years ago, few thought it was feasible to find DNA in stool to screen for colon cancer and look at the impact Cologuard has made today—more than two million people screened. That’s my mentality every day and something that sometimes keeps me awake; searching out the next big problem in health care and envisioning how our team can solve it.
MD+DI: Finally, where do you see Exact Sciences in five years? What is your outlook for the future of the company?
Conroy: Exact Sciences has a bright future. We’re in the best position to lead in earlier cancer detection. We have the right experience. We have the right team. And, importantly, we have the science and technology to find cancer earlier. With these tools, we can develop a variety of noninvasive tests for the earlier and more accurate detection of the deadliest cancers, supporting our goal to improve outcomes and change lives. Whether that’s growing Cologuard or introducing new cancer diagnostics, the smart work our dedicated team does every day to make progress in the earlier detection of cancer has tremendous potential.