Kevin Conroy is a longtime leader in the biotechnology industry and currently President, CEO, and Chairman of Exact Sciences, a company based in Madison, Wisconsin. Exact Sciences has made great strides since its near failure back in late 2008/early 2009. Its Cologuard product for screening colon cancer in stool samples was recently FDA approved and covered by Medicare. Today I wanted to ask him about what this news means for the company and to hear his take on what this new test means for cancer screening changes to come.
Tom Fowler, Medgadget: What is the biggest change you have overseen since leading the helm at Exact Sciences?
Kevin Conroy: When I started as CEO at Exact Sciences in April of 2009, there were four employees at the company, almost no money in the bank and no test that had been successful in screening in a noninvasive way for colorectal cancer. Our goal was to develop a colorectal cancer screening test that would vastly improve the effectiveness of the stool-based DNA testing that was currently being done.
To achieve this, we had to find a partner to bring this vision to reality and eventually to market. We found that in the Mayo Clinic. We also hired a world-class CSO to develop the test and run a prospective, 90-site, 10,000-patient clinical trial, the DeeP-C Trial, whose results were published in the New England Journal of Medicine. The results showed that Cologuard detected 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients and achieved a specificity of 87 percent.
This was a whole new path for the company. We had to develop a highly accurate, noninvasive colorectal cancer screening test while building the company exponentially.
Medgadget: As someone with a background in engineering, how involved does a CEO get in the development side of the biotech business?
Kevin Conroy: As CEO, I am involved in every facet of the company. I enjoy being a part of product development. My goal is also to make sure that we have the very best scientific leadership at Exact Sciences to carry out top-notch R and D work so we can offer the very best products. My role is to help guide the definition for what is needed in a colon cancer screening test that will succeed in the marketplace. We need precise science behind the product, but we also need to know that it’s a practical medical advancement that will work for both physicians and patients.
Medgadget: Tell me about Cologuard, what is something this test offers that has never been available before?
Kevin Conroy: Cologuard is the first and only FDA-approved noninvasive stool-based DNA screening test for colorectal cancer. We haven’t been able to test noninvasively with such high sensitivity before this test. There are no medication or dietary restrictions, and there is no bowel preparation necessary to take the test, and the accuracy of the test sets a new precedent. Results from our DeeP-C clinical trial show Cologuard finds 92% of cancers, where the FIT test, which only looks for blood in the stool, finds only 74%.
Medgadget: Have you personally used Cologuard? Is it easy to use?
Kevin Conroy: I have taken the Cologuard test, as part of a study and it is extremely easy, private and convenient to use. The test is delivered to a patient’s door, the stool sample is deposited in the collection kit, and is sent back to the Exact Sciences lab for processing. With no bowel preparation necessary and not even having to leave my house to screen for colon cancer, it is by far one of the simplest medical screening tests I have taken.
Medgadget: During the next decade what will be the largest change in laboratory practices in America?
Kevin Conroy: In the next decade, we can expect to see a wide utilization of DNA technology that will change the way patients are screened, diagnosed and ultimately treated. We will see more and more DNA-based research and technologies translated into practical, real-world medical applications.
Medgadget: What advice would you give to medical technology visionaries that are just starting their careers?
Kevin Conroy: My advice to those just starting out is that it is key to find big problems that need to be solved rather than updating or adding minor improvements to technologies already in existence. Strive to bring the very best clinicians and scientists together to work on innovations. This is vital to the development of innovations that can be both life-changing and life-saving. With the right science and expert medical teams working on a problem together, you are much more likely to develop an innovative solution to an unmet need.
Link: Exact Sciences…