GenMark Diagnostics receives FDA clearance for RVP test

Sept. 20, 2012

GenMark Diagnostics, Inc., provider of automated, multiplex molecular diagnostic testing systems, has announced that it has received 510(k) clearance from the FDA for its eSensor Respiratory Virus Panel for use on its XT-8 system. This test is intended to simultaneously detect and differentiate 14 clinically relevant viruses from patients with influenza-like illness. According to GenMark representatives, the eSensor RVP test has the potential to significantly improve patient care by delivering superior co-infection detection, distinguishing rhinoviruses from enteroviruses, and identifying clinically relevant adenoviruses. They further assert that the product offers rapid processing and requires minimal hands-on time from laboratory staff, thus enabling clinical labs to rapidly report actionable patient results to physicians while efficiently managing the fluctuating testing workload associated with this seasonal illness.

“The FDA clearance of our eSensor Respiratory Virus Panel test further demonstrates the capability of our electronic detection technology,” comments Hany Massarany, GenMark's President and CEO. “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.” Read more about the respiratory virus panel and other multiplex molecular diagnostics systems and assays provided by GenMark Dx in the “Executive Snapshot” feature in the current (September 2012) issue of MLO.