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2010: A Year of
Strong Execution
Product Development
- Completed pre-clinical validation study
- Developed extraction & detection assays
- Developed quality system
Clinical Trial Planning
- Agreement with FDA on key elements of study design
- Built experienced internal & external teams, including clinical research organization
- Qualified >30 enrollment sites, with a goal of >40
Market Development
- Developed initial U.S. go-to-market plan
- Educated key physicians, labs, payors & advocates
- Evaluated ex-U.S. market
