GenMark Receives FDA Emergency Use Authorization for ePlex SARS-CoV-2 Test

(Carlsbad, CA, USA), a provider of automated, multiplex molecular diagnostic testing systems, has received the US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for the company’s ePlex SARS-CoV-2 Test.

GenMark’s multiplex molecular diagnostic solutions are designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. Utilizing GenMark's proprietary eSensor detection technology, the company’s eSensor XT-8 and ePlex systems are designed to support a broad range of molecular diagnostic tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark’s ePlex: The True Sample-to-Answer Solution is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream, and gastrointestinal infections.

GenMark’s ePlex SARS-CoV-2 Test was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for patients suspected of COVID-19 by their health care provider. The test is exclusively for use on the company’s ePlex system, which had a global installed base of more than 500 analyzers as of December 31, 2019. The ePlex sample-to-answer system provides an automated solution to the diagnostic process and provides results in under two hours with the capacity to process up to 96 tests per eight-hour shift. The ePlex system’s modular and expandable design enables near-patient COVID-19 testing to be widely accessible to meet the needs of various types of laboratories, from small decentralized sites, to large central hospitals and laboratories.

“Because ePlex enables near-patient testing and is available in hospitals and labs across the US and in more than 30 countries, results can be returned to doctors and patients more rapidly than with other platforms. Our unique ability to quickly diagnose and begin treatment of critically ill patients addresses the challenges associated with the coronavirus pandemic. We are proud of our team’s ability to rapidly respond to this urgent public health crisis,” said Scott Mendel, Interim Chief Executive Officer. “The FDA’s Emergency Use Authorization of our test supports GenMark’s commitment to provide critical and actionable diagnostic information to healthcare providers so that they can better manage their patients.”

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GenMark Diagnostics, Inc.