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GenMark seeks FDA approval for ePlex respiratory pathogen panel

GenMark Diagnostics is seeking approval from the US Food and Drug Administration (FDA) for its ePlex sample-to-answer instrument and respiratory pathogen panel.

The company has submitted 510(k) applications to the FDA for the ePlex panel.

The ePlex will provide molecular diagnostic panels on a scalable sample-to-answer system, helping to carry out syndromic infectious disease testing in hospital and reference laboratories.

GenMark’s panel has been designed to detect the most clinically relevant viral and bacterial targets from nasopharyngeal samples.

It can incorporate and integrate the entire process ranging from nucleic acid extraction and amplification to detection, interpretation and reporting.

The ePlex, which can complete the work in around two minutes, aggregates digital microfluidics with GenMark's eSensor electrochemical detection technology that helps in precise fluid management and providing accurate results.

The system includes bi-directional integration to laboratory information systems (LIS), a patented technology for positive patient identification and customer support through remote access.

In Europe, the company launched ePlex instrument and respiratory pathogen panel in June this year.

GenMark president and CEO Hany Massarany said: "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.

“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.”