Molecular Syndromic Test for Respiratory Infections Achieves CE Mark

GenMark Diagnostics, Inc has 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 US 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.

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 admission.

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.

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