GenMark submits 510(k) applications to FDA for ePlex instrument, panel
GenMark Diagnostics announced that it has submitted 510(k) applications to the FDA for its ePlex sample-to-answer instrument and Respiratory Pathogen Panel. "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. Our teams continue to focus on the global commercialization of ePlex and the expansion of its menu. We expect our Blood Culture ID family of panels, including the Gram Positive, Gram Negative, and Fungal panels, to be available in Europe during the first quarter of 2017," said Hany Massarany, President and CEO of GenMark.