GenMark Diagnostics submits 510(k) applications to the FDA for ePlex® sample-to-answer instrument and Respiratory Pathogen Panel

GenMark Diagnostics, a provider of automated, multiplex molecular diagnostic testing systems, announced 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. The system fully integrates and automates the entire process from nucleic acid extraction and amplification, through detection, interpretation and reporting. Workflow has been optimized requiring approximately two minutes of hands-on time and includes bi-directional integration to Laboratory Information Systems (LIS), a patented technology for positive patient identification, and the ability to provide customer support via remote access. ePlex combines innovative digital microfluidics with GenMark’s eSensor® electrochemical detection technology, to enable precise fluid management and accurate results. The ePlex Respiratory Pathogen Panel is designed to detect the most clinically relevant viral and bacterial targets from nasopharyngeal samples. The ePlex instrument and Respiratory Pathogen Panel were launched in Europe in June, 2016.

“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,” said Hany Massarany, President and Chief Executive Officer of GenMark. “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,” added Massarany.