GenMark Diagnostics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its eSensor Respiratory Virus Panel(RVP) for use on its XT-8 system.
The eSensorRVP test simultaneously detects and differentiates 14 clinically relevant viruses from patients with influenza-like illness.
The test will also improve patient care by delivering superior co-infection detection, distinguishing Rhinovirus from Enteroviruses and identifying clinically relevant Adenoviruses, according to the company.
The eSensor RVP test will enable clinical laboratories to report patient results to physicians, since it takes minimal hands of laboratory staff and processing time.
GenMark president and CEO Hany Massarany said the FDA clearance of its eSensor Respiratory Virus Panel test furthers the 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.
