NEW YORK – GenMark Diagnostics said on Wednesday that it has submitted its ePlex SARS-CoV-2 test for Emergency Use Authorization (EUA) by the US Food and Drug Administration.
If the FDA concludes the company has met the agency's criteria for issuance of an EUA, GenMark will begin shipping test kits to customers for routine clinical use.
GenMark's coronavirus assay runs on its ePlex sample-to-answer molecular diagnostic system, which is based on competitive DNA hybridization and electrochemical detection technology.
"EUA submission in just over a week from the initial [research use only] shipments of our ePlex test is a critical step to enable our customers to rapidly detect and possibly prevent the spread of the COVID-19 virus," Scott Mendel, GenMark's interim CEO, said in a statement.
The Carlsbad, California-based firm shipped RUO tests last week to key customers to validate the assay design using clinical samples.
Northwell Health, a GenMark collaborator, has provided clinical sample data to expedite the company's efforts, according to Dwayne Breining, the healthcare network's executive director of labs.
On Tuesday, the Chan Zuckerberg Initiative and Biohub said that they have formed a COVID-19 task force with the University of California, San Francisco and Stanford University to invest in two ePlex platforms and boost testing capacity in the Bay Area, pending EUA.
In morning trading on the Nasdaq, GenMark's shares were up 8 percent to $5.15.