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GenMark eSensor Respiratory Virus Panel wins FDA nod

GenMark Diagnostics has obtained the US Food and Drug Administration's (FDA) 510(k) clearance for its eSensor Respiratory Virus Panel, designed for use on its XT-8 system.

The test is intended to simultaneously detect and differentiate 14 clinically relevant viruses including rhinovirus from enteroviruses and identify clinically relevant Adenoviruses from patients with influenza-like illness.

GenMark president and CEO Hany Massarany said the FDA clearance of the company’s eSensor Respiratory Virus Panel test further demonstrates the capability of its differentiated electronic detection technology.

"The FDA review process, which was both collaborative and thorough, resulted in a 510(k) clearance which supports performance claims that we believe will meet customer needs and expectations, especially with regard to specificity, sensitivity and limits of detection," Massarany added.