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Medical Devices / Submissions and Approvals

GenMark Wins FDA Market Clearance for Its ePlex Instrument and Respiratory Pathogen Panel

June 13, 2017

The FDA has granted marketing clearance to both GenMark’s ePlex instrument and Respiratory Pathogen (RP) panel.

ePlex is an in vitro diagnostic platform that integrates nucleic acid extraction, amplification and detection processes into an automated, sample-to-answer system.

The ePlex RP panel detects more than 20 viral and bacterial pathogens that commonly cause upper respiratory infections.

This device will be made available in the U.S. in the second half of 2017. — Cynthia Jessup

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