Closer To "Go Time", GenMark Diagnostics's Ability To Execute Is Still A Key Question

Hard as it can be to develop a new diagnostic system and get it though the FDA approval process, that's only part of the battle in achieving success in the diagnostics market. GenMark (NASDAQ:GNMK) has weathered some ups, downs, and delays on its path to market for its new ePlex system, but the company should receive FDA 510(k) approval for the system within weeks and begin launching a system that could deliver over (and perhaps well over) $1 billion in revenue to this small-cap med-tech company.

Of course, it's never quite that simple. GenMark has had its issues reaching the milestones laid out by management on time, and that still remains the case. With U.S. approval looming, significant questions remain regarding management's ability to execute on manufacturing and sales, to say nothing of how the ePlex will fare in the real world against competing systems from bioMerieux (OTC:BMXXY), Luminex (NASDAQ:LMNX), Danaher's (NYSE:DHR) Cepheid, and other existing or would-be players in the market.

I'd still describe myself as cautiously bullish on GenMark, as I believe ePlex is a good platform that answers many of the challenges and needs of hospital and lab customers. The shares have continued to head higher since my last update (though it has been a bumpy ride), though, and the risk/reward isn't quite as favorable as it has been.

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Closer To "Go Time", GenMark Diagnostics's Ability To Execute Is Still A Key Question