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

Combination test for COVID-19, flu and other common respiratory illnesses helps health care professionals prepare for flu season

RP2 Panel at a Glance

• GenMark’s ePlex Respiratory Pathogen Panel 2 (RP2 Panel) has received Emergency Use Authorization from the FDA.
  
  
• The RP2 Panel provides results in less than two hours for more than 20 viruses and bacteria that cause common respiratory infections with similar symptoms, including COVID-19, flu, bronchitis and the common cold.
  
  
• The rapid, multiplex molecular testing offered by the RP2 Panel will be vital in preparing for the fall and winter, when COVID-19 will be circulating along with flu and other common respiratory infections, helping doctors quickly and effectively treat seriously ill patients.

CARLSBAD, Calif., Oct. 08, 2020 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (NASDAQ: GNMK), a leading 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.