The ePlex Respiratory Pathogen Panel 2 (RP2 Panel) from GenMark Diagnostics, Carlsbad, Calif, has received FDA emergency use authorization. The RP2 Panel provides results in less than 2 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 multiplex molecular testing the RP2 Panel offers will be vital in preparing for the fall and winter, when covid-19 will be circulating along with flu and other common respiratory infections, and doctors will need to make accurate diagnoses quickly in order to provide effective treatment for seriously ill patients.
“COVID-19 is placing a spotlight on the importance of fast, comprehensive molecular testing,” says 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.
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.
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).
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 been cleared by the FDA and achieved CE Mark. In March, GenMark received EUA for its ePlex SARS-CoV-2 Test.
The ePlex RP2 Panel has been funded 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.
For more information, visit GenMark Diagnostics.