NEW YORK – GenMark Diagnostics said Monday that it has been awarded a grant from the US Department of Health and Human Services (HHS) of up to $749,000 to develop and pursue US Food and Drug Administration Emergency Use Authorization (EUA) for a diagnostic panel that incorporates a new SARS-CoV-2 viral target into the company’s existing ePlex Respiratory Pathogen (RP) panel.
With the funding, awarded by the HHS Biomedical Advanced Research and Development Authority (BARDA), GenMark expects to complete the development work necessary to request an EUA from the FDA for the new panel, which it has named the ePlex RP2 Panel.
GenMark said its ePlex RP2 Panel will leverage its ePlex instrument, which was FDA cleared for use with its ePlex Respiratory Pathogen and Blood Culture Identification panels. The firm recently received EUA for a SARS-CoV-2 test running on the system.
The FDA has categorized the ePlex system and tests as moderately complex under CLIA, which would enable its use in a broad array of hospital and reference lab settings, GenMark said.
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, the firm said.
GenMark noted that according to recent evidence, a high percentage of patients with SARS-CoV-2, the coronavirus that causes COVID-19, are also infected with other respiratory viruses, emphasizing the importance of testing for a broad panel of respiratory pathogens.