GenMark Diagnostics Announces Commercial Launch of its ePlex® Respiratory Pathogen Panel 2 (RP2)
CARLSBAD, Calif., June 29, 2020 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (NASDAQ:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, announced that its ePlex® Respiratory Pathogen 2 (RP2) Panel is now available for U.S. commercial distribution and clinical use. The ePlex RP2 Panel is one of the first rapid-result multiplex panel tests that can identify 21 pathogens, including SARS-CoV-2, to be made available for clinical use. The company also submitted an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration for the ePlex® Respiratory Pathogen 2 (RP2) Panel earlier this month.
The ePlex RP2 Panel is designed to provide results for SARS-CoV-2 – the virus that causes COVID-19 – in addition to a number of other common respiratory pathogens, including influenza, adenovirus, rhinovirus and respiratory syncytial virus (RSV), in under two hours. The panel also includes a new, simplified workflow making it even easier for labs to run the test. The ability to quickly determine the cause of infections will be vital in the fall and winter when many of these respiratory pathogens are likely to be circulating, along with SARS-CoV-2.
Incorporating the SARS-CoV-2 assay into the existing ePlex RP Panel is intended to streamline 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.1
“The ePlex RP2 Panel is designed to enable clinicians to quickly determine the cause of infection and the best course of treatment. This is especially vital for individuals who are vulnerable, such as the elderly, people with compromised immune systems, and children, and therefore at increased risk for the new coronavirus and other common and often serious respiratory illnesses,” said Scott Mendel, President and CEO of GenMark. “One recent study highlighted that about 20% of COVID-19 patients are also infected with other respiratory pathogens.2 Syndromic panels that provide broad coverage of viruses and bacteria from one patient sample will be critical this flu season, which is expected to coincide with continued SARS-CoV-2 infections.”
Incorporating the SARS-CoV-2 test into the existing ePlex RP Panel is expected to improve GenMark’s manufacturing efficiency and output and increase the number of respiratory panels (including COVID-19 tests) the company can supply. GenMark continues to invest in maufacturing capacity improvements to scale and meet future testing demand.
The ePlex RP2 Panel is designed for use with the company’s ePlex system, which has been cleared by the FDA for use with the ePlex Respiratory Pathogen (RP) Panel and Blood Culture Identification (BCID) Panels (Gram-positive, Gram-negative and Fungal pathogens). 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.
The ePlex RP2 Panel has been funded in whole or in part with Federal funds from the 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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