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# FDA Clears GenMark ePlex/Respiratory Panel
- URL: https://www.fdaweb.com/fda-clears-genmark-eplex-respiratory-panel/
- Published: 2017-06-12T12:00:00.000Z
- Updated: 2026-09-14T22:28:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138910

FDA has cleared a GenMark Diagnostics 510(k) for both its ePlex instrument and Respiratory Pathogen Panel. The company describes ePlex as a transformational new *in vitro* diagnostic platform that integrates nucleic acid extraction, amplification, and detection processes into an automated, sample-to-answer system. The panel detects over 20 viral and bacterial pathogens that commonly cause upper respiratory infections.