GenMark Diagnostics' ePlex® Respiratory Pathogen Panel 2 (RP2) achieves CE Mark
Molecular syndromic test for COVID-19, influenza and other common respiratory pathogens
RP2 Panel at a Glance
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 GenMarkRP 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
“Getting the results in hours rather than days was a massive improvement and totally revolutionized the way our emergency department works,” said Lisa Mead, Head Biomedical Scientist (Acting), York Teaching Hospitals. “When flu season begins this year, we plan to stay ahead of the curve by running GenMark’s RP2 test on all patients who are admitted. We are confident that being able to test patients for a wide variety of viruses will make a significant difference in helping us quickly and most effectively manage patients during what is sure to be a challenging flu season now that coronavirus is in the mix.”
RP2 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 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 achieved CE Mark.
The ePlex RP2 Panel has been funded in part with federal funds from the United States Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00022. Visit https://www.genmarkdx.com/solutions/panels/eplex-panels/respiratory-pathogen-panel/ to learn more about the ePlex RP2 Panel.
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