Genmark diagnostics receives FDA 510(k) market clearance for its ePlex blood culture identification gram-positive panel

GenMark Diagnostics, a provider of automated, multiplex molecular diagnostic testing systems, announced that it has received FDA 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel. This panel, together with the ePlex Blood Culture Identification Gram-Negative (BCID-GN) and Fungal Pathogen (BCID-FP) Panels, were developed for the diagnosis and disease management of bloodstream infections (BSI) that can to sepsis.

Developed on the ePlex sample-to-answer system, the BCID Panels deliver novel benefits designed to improve patient care and antimicrobial stewardship (AMS) with the broadest organism inclusivity and resistance gene coverage. By coupling GenMark’s BCID Panels with the ePlex “Templated Comments” software module, hospitals can enable immediate intervention linked to a diagnostic result and improve effectiveness of AMS initiatives. The ePlex BCID-GP Panel includes important BSI causing pathogens and unique targets to aid in rapidly ruling out blood culture contamination.

We are excited to offer customers additional tools to improve the identification and management of bloodstream infection. Additionally, our ePlex software platform links results from these tests to localized antimicrobial stewardship guidelines to help guide treatment decisions, which will save critical time for patients and healthcare providers alike,” said Hany Massarany, President and Chief Executive Officer. “Test menu expansion will remain a priority for us as we continue our diligent development and clinical efforts to unlock the full potential of the ePlex system. We are pleased to exit the year with two FDA-cleared panels, and with the BCID-GN and BCID-FP Panels in the later stages of the regulatory process.

GenMark’s BCID-GN and BCID-FP Panels were submitted to the FDA in September 2018 and are still currently under review.