GenMark Diagnostics (NASDAQ:GNMK) reports revenue growth of 13% to $14.9M vs. analyst estimate of $14.83M.
For FY2016 the company expects revenue to be $49.2M (+25% Y/Y) vs. $49.13M consensus.
The Company finished the year with more than 55 customer agreements in place totaling over 85 ePlex instruments.
“Fourth quarter revenue was in line with our expectations, despite a slow start to the flu season. Furthermore, we are very pleased with the increasing customer interest in our ePlex sample-to-answer system, particularly following our submissions to FDA last month. We finished the year with more than 55 agreements for over 85 ePlex instruments, many of which have already been installed in end-user sites. Customer feedback has been very positive, especially on ease of use and workflow,” said Hany Massarany, President and Chief Executive Officer of GenMark.
GenMark Diagnostics (NASDAQ:GNMK) announces that it has submitted 510(k) applications to the FDA for its ePlex sample-to-answer instrument and Respiratory Pathogen Panel.
ePlex will offer comprehensive molecular diagnostic panels on a scalable sample-to-answer system, designed to enable syndromic infectious disease testing in hospital and reference laboratories. ePlex combines innovative digital microfluidics with GenMark’s eSensor electrochemical detection technology, to enable precise fluid management and accurate results.
Hany Massarany, President and CEO of GenMark says, "We designed ePlex to improve patient outcomes while optimizing laboratory workflow and efficiency. Feedback from European customers and U.S. clinical trial sites reinforces this unique value proposition of ePlex.”
Thinly traded micro cap GenMark Diagnostics (GNMK -26.4%) is off on 30% higher volume, albeit on turnover of only 320K shares, in response to its disclosure in yesterday's earnings call that the European launch of its ePlex System will be delayed until Q1.
The culprit is an unacceptably high level of variability in the reliability of the tests due to a particular injection molded part in the ePlex cartridge. The ability to manufacture two components which play key roles in the maintenance of reliable cartridge fluidics during operation has apparently been a challenge.