GenMark diagnostics (GNMK), a provider of automated, multiplex molecular diagnostic testing systems announced it has been awarded a grant from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).
In working with public and private partners to find solutions to mitigate the impact of COVID-19, BARDA will provide GenMark with up to $749,000 in funding to develop and pursue U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of a diagnostic panel that incorporates the new SARS-CoV-2 viral target into the company’s existing ePlex Respiratory Pathogen (RP) panel. With this additional support from BARDA, GenMark expects to be able to complete the development work necessary to request an EUA from the FDA for the ePlex RP2 Panel.
GenMark’s ePlex RP2 Panel will leverage the company’s ePlex instrument that has been FDA cleared for use with its ePlex Respiratory Pathogen (RP) Panel, Blood Culture Identification (BCID) Panels (Gram-positive, Gram-negative and Fungal pathogens), and most recently the Emergency Use Authorization of a SARS-CoV-2 Test. The FDA has categorized the ePlex system and tests as Clinical Laboratory Improvement Amendments (CLIA) moderately complex, allowing for its use in a broad array of hospital and reference lab settings. The new test will be developed for the qualitative detection of respiratory pathogens in nasopharyngeal swab samples. The addition of the SARS-CoV-2 target to the existing ePlex RP Panel will allow for rapid, streamlined testing for respiratory illnesses, saving time and valuable hospital resources that are critically limited at this time. Recent evidence shows a high percent of COVID-19 patients are also infected with other respiratory viruses, making it even more important to test for a broad panel of respiratory pathogens.
“We are very honored to receive this support from BARDA to continue the development of our ePlex RP2 Panel,” said Scott Mendel, Interim Chief Executive Officer. “Providing a single test with comprehensive, rapid and actionable results across a broad range of viral and bacterial pathogens enables improved patient outcomes. Our team fully understands the urgency to develop this expanded RP panel and we will work hard to deliver exactly that.”
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