GenMark Diagnostics Announces Commercial Launch of its ePlex Respiratory Pathogen Panel 2 (RP2) - Seite 2

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 manufacturing 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-pa ... to learn more about the ePlex RP2 Panel.

About Emergency Use Authorization Status
The GenMark ePlex RP2 Panel has been made available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the use of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA cleared IVD. However, based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of COVID-19. The EUA for this test is in effect for the duration of the COVID-19 emergency, unless terminated or revoked (after which the test may no longer be used). An FDA cleared IVD should be used instead of an IVD under EUA, when applicable and available.