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GenMark Expects 28 Percent Rise in Q1 Revenues; Aims for Q4 European ePlex Launch

NEW YORK (GenomeWeb) – GenMark Diagnostics yesterday reported that it expects a 28 percent rise in its first quarter revenues to $10.1 million amid the placement of 22 of its XT-8 analyzers during the period. The total installed base of analyzers in the US is now 562.

The firm reiterated its full-year 2015 revenue guidance of between $38 million and $40 million.

GenMark also said that it expects to launch its ePlex sample-to-answer molecular diagnostics system in Europe in the fourth quarter of this year, and to submit it for approval to the US Food and Drug Administration in the first quarter of next year.

"We are confident in the design of the ePlex system and continue to generate excellent results with tests conducted on full ePlex consumables and beta instruments," GenMark President and CEO Hany Massarany said in a statement.

"We are currently working on the transfer of our fully integrated consumable to manufacturing, with continued focus on reliability and production scale-up to support the levels required for clinical studies and European launch," he added. "This is taking longer than we originally expected, however, it's absolutely required to meet … quality and reliability standards."

GenMark had previously said the ePlex system would launch in Europe around the beginning of 2015, but later pushed that timeline back to midyear.