The Carlsbad, California-based provider of automated, multiplex molecular diagnostic testing systems announced initial shipments of ePlex Research Use Only test kits designed to detect COVID-19 virus to its Hong Kong distributor as well as several U.S. customers that have access to clinical samples.
The company said it plans to use this information to support submission of an Emergency Use Authorization, or EUA, to the FDA.
"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," interim CEO Scott Mendel said in a statement.
Separately, the company reported fourth-quarter results, showing 24% year-over-year revenue growth and a narrower loss of 17 cents per share — a penny wider than the 16 cents per share loss estimated by analysts.
GenMark shares were rallying 27.92% to $4.49 at the time of publication, while Co-Diagnostics was moving in sympathy, down 16.11% at $14.94.