Benchmark is initiating coverage of Exact Sciences Corporation EXAS with a Buy rating and $9 price target. Exact is developing the Cologuard stool-based DNA test with the intention of being the first non-invasive screening diagnostic that can prevent colorectal cancer by detecting dangerous pre-cancerous polyps in addition to cancer.
In the second half of 2014 Benchmark anticipates Cologuard will receive FDA marketing clearance and simultaneous CMS reimbursement, which provides substantial competitive distinction over competing laboratory developed tests. Benchmark anticipates substantial long-term share appreciation supported by incremental validation study results in 2011 and PMA study top line results in Q4, 2012.
Benchmark believes Exact Sciences Corp. shares are likely to appreciate based on favorable additional validation data in 2011 and PMA study data forecast in 4Q12 that should exceed the FDA's 65% lower bound of sensitivity confidence threshold. Benchmark believes these are relatively low-risk events that offer good return potential over the next two and one-half years. It sees attractive opportunities with an addressable market between approximately $1.2 billion for the value of the current fecal testing market, and up to $8 billion for the entire U.S. addressable market.
Exact Sciences closed Wednesday at $7.57
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