GenMark Diagnostics announces submission of emergency use authorization for its eSensor SARS-CoV-2 test

GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, announced that it has notified the U.S. Food and Drug Administration (FDA) of the intent to commercially distribute the eSensor^® SARS-CoV-2 Test for clinical use. The company has also submitted an Emergency Use Authorization (EUA) to the FDA for its eSensor^® SARS-CoV-2 Test.

The eSensor SARS-CoV-2 test utilizes the design principles of GenMark’s eSensor Respiratory Viral Panel (RVP), which has been recognized as one of the most sensitive RVP assays available1. The eSensor SARS-CoV-2 Test consists of PCR amplification and detection reagents and eSensor SARS-CoV-2 test cartridges which run on GenMark’s XT-8 System. The XT-8 is GenMark’s legacy multiplex molecular diagnostic system.

“We developed this product and submitted the EUA to leverage our available eSensor test capacity and XT-8 installed base to further help with addressing COVID-19 testing demands,” said Scott Mendel, President and CEO of GenMark. “The COVID-19 testing approach for some institutions is better aligned to large batch-based testing for which the eSensor XT-8 workflow is well suited. This provides our over 100 customers still using the eSensor XT-8 system an opportunity to expand their COVID-19 testing capabilities.”

The eSensor SARS-CoV-2 Test can provide results for 96 samples in 5 hours. Core labs in the hospital and reference labs have the expertise, equipment and workflow to accommodate 96-well plate processing of clinical specimens and with four batched runs can process 384 specimens per day.

Upon completion of the FDA notification process, GenMark’s eSensor SARS-CoV-2 Test is commercially available while under EUA review by the FDA. GenMark earlier this year announced the launch of its ePlex^® SARS-CoV-2 Test and the ePlex^® Respiratory Pathogen Panel 2 (RP2), which detects 21 pathogens, including SARS-CoV-2, both of which run on the Company’s sample-to-answer ePlex System.

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