GenMark Diagnostics’ ePlex Respiratory Pathogen Panel 2 (RP2) achieves CE Mark

Molecular syndromic test for COVID-19, influenza and other common respiratory pathogens
helps health care professionals prepare for flu season

RP2 Panel at a Glance

• GenMark’s ePlex Respiratory Pathogen Panel 2 (RP2) has achieved CE mark.
  
  
• RP2 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, influenza A and B, respiratory syncytial virus (RSV) and rhinovirus.
  
  
• The rapid, multiplex molecular testing offered by RP2 will be vital this fall and winter, when COVID-19 coincides with flu and other common respiratory infections, helping doctors quickly diagnose and effectively treat seriously ill patients.

CARLSBAD, Calif., Sept. 14, 2020 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (NASDAQ: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced that it has achieved CE Mark under the European In‐Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex Respiratory Pathogen Panel 2 (RP2). The molecular test provides results in less than two hours for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, influenza A and B, respiratory syncytial virus (RSV) and rhinovirus. This panel was previously made commercially available in the U.S. and is awaiting Emergency Use Authorization by the FDA.

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

“Fast and comprehensive molecular testing has become even more essential since the arrival of COVID-19,” said Scott Mendel, President and CEO of GenMark. “Cold and flu season is right around the corner and while we can’t predict what it will be like, healthcare systems and providers must be prepared. Syndromic testing will be vital in helping health care professionals accurately diagnose seriously ill patients with similar symptoms, speeding up treatment and helping improve resource management.”

After the 2016-2017 winter flu and virus season, York Teaching Hospitals in in the United Kingdom (including a 700-bed hospital in York and a 300-bed hospital in Scarborough) switched to in-hospital multiplex testing with GenMark’s ePlex system. Offsite syndromic testing during the flu season resulted in slow turnaround time and negatively affected bed management, so the benefits of the GenMark RP panel were huge, leading to 9,111 bed days saved the first year (2017-2018) and 13,971 bed days the second year (2018-2019) compared to 2016-2017.¹