GenMark Diagnostics’ ePlex RP2 receives EUA from FDA

GenMark Diagnostics Inc., 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). 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.

A multiplex – or syndromic – test, the RP2 Panel provides rapid results for infections with similar symptoms such as fever, cough and body aches, which will be essential in preparing for fall and winter as the flu season coincides with the ongoing risk of COVID-19.

“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.1 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% reduction in hospital admissions.2

The ePlex RP2 Panel is also approved as a tool for clinical diagnosis in the European market, having announced CE Mark achievement on Sept. 8, 2020 under the European In‐Vitro Diagnostic Devices Directive (98/79/EC).  – MB Bureau