GenMark Diagnostics’ ePlex Respiratory Pathogen Panel 2 (RP2) receives EUA from FDA

Oct. 9, 2020

GenMark Diagnostics – a provider of automated, multiplex molecular diagnostic testing systems – has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its ePlex Respiratory Pathogen Panel 2 (RP2), according to a press release. In less than two hours, the test provides results for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, flu, bronchitis and the common cold.

“COVID-19 is placing a spotlight on the importance of fast, comprehensive molecular testing,” said Scott Mendel, President and CEO of GenMark. “While we can’t predict what cold and flu season is going to look like this year, we know that we have to arm healthcare providers with the necessary tools to quickly and accurately diagnose the cause of infections in seriously ill patients, so syndromic testing is going to be critical.”

Some COVID-19 patients are infected with more than one pathogen, known as coinfection, making accurate identification of the cause of infection even more important. Further, sepsis – a life-threatening response to infection – can be a complication for hospitalized COVID-19 patients, and many receive antibiotics inappropriately. Rapid molecular tests help address the double burden of infections by quickly identifying or ruling out the responsible pathogen or pathogens to enable proper treatment, minimizing unnecessary use of antibiotics, which can save lives and reduce antibiotic resistance.

The RP2 Panel includes a new, simplified workflow making it even easier for labs to run the test. Incorporating COVID-19 into the existing ePlex Respiratory Pathogen (RP) Panel streamlines the diagnostic process for hospitals by allowing them to check for multiple pathogens with a single test, saving time and resources and improving bed management. A study at two acute large tertiary care hospitals demonstrated that using the ePlex RP Panel in the Emergency Department led to earlier patient results, which resulted in an 8.4 percent reduction in hospital admissions.

The ePlex RP2 Panel is designed for use with the company’s ePlex system, along with the ePlex RP Panel and Blood Culture Identification (BCID) Panels (gram-positive, gram-negative and fungal pathogens), all of which have been cleared by the FDA and achieved CE Mark. In March, GenMark received EUA for its ePlex SARS-CoV-2 Test. Certified by the FDA under the Clinical Laboratory Improvement Amendments (CLIA) as moderately complex, the ePlex system is easy to operate and can be used in a wide variety of hospital and reference lab settings.

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