1. One of the Most Prevalent and Preventable Cancers Could See a Highly Effective Early Detection Test
“While companies are focused on treating cancers [in stage] 3 & 4, our goal is to avoid that necessity” explains Exact Sciences CEO Kevin Conroy about Cologuard, the colorectal cancer screening test his company is developing. Colorectal cancer is the most preventable cancer because of the simplicity of surgical removal, and 90% of patients will survive if their cancer is detected in stage 1 or 2.
2. ColoGuard: the Science and Medicine Behind the Diagnostic
Mark Monane and Kevin Conroy discuss the procedure for collecting and processing samples. Exact sciences looks for DNA methylation markers, DNA mutation markers, and protein markers in a patient’s stool in order to determine the likelihood of colorectal cancer or pre-cancer.
3. Getting to Market: Regulatory Pathway, Clinical Trial Design, Timeline, Risk Analysis
Exact Sciences will have to recruit 10,000 patient for its $20MM PMA study, which will compare Cologuard against invasive and non-invasive standards. Kevin Conroy and Mark Monane discuss the timeline of the study and expected market availability. Mark Monane asks: “what could go wrong with your plan?”
4. Commercialization: from Approval to the Billion Dollar Revenue
Mark Monane and Kevin Conroy discuss the commercialization of Exact Sciences’ Cologuard diagnostic. There are 2 different strategies: screen the unscreened (who shy away from invasive procedures), and screen in between colonoscopies (which are every 10years). How much will this test cost? Why should payers be interested? What would prevent anyone from copying Cologuard? Who are Exact Sciences’ competitors? What is Exact Sciences’ cash situation? Following this Q&A, Mark Monane concludes with a word association game.
This interview was conducted at the NASDAQ Marketsite, on March 28th, 2011, in New York City.
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