GenMark Diagnostics, Inc., announced the initial shipments of ePlex Research Use Only (RUO) test kits designed to detect the SARS-CoV-2 virus. Initial RUO test kits were recently shipped to the company’s Hong Kong distributor, as well as several U.S. customers that have access to clinical samples. GenMark plans to use this information to support submission of an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the ePlex SARS-CoV-2 test to address this developing global public health emergency.
“In just one month, our team completed the design, manufacture and shipment of initial tests to customers for validation of our assay design using clinical samples. This is a strong demonstration of the GenMark teams’ scientific and operational expertise, the capability of our novel ePlex technology, and our ability to quickly adapt ePlex to meet a specific market need,” said Scott Mendel, Interim Chief Executive Officer.
He added, “COVID-19 is a global health emergency and we believe it is important to use our technology and resources to contribute in the fight against this disease. We are pursuing FDA’s EUA regulatory pathway for this test with the goal to provide broad access to an easy-to-use, sample-to-answer solution for detection of this emerging virus.”
