GenMark Diagnostics Submits Test for Coronavirus to FDA

GenMark Diagnostics submitted a test for coronavirus to the Food and Drug Administration. The company seeks quick clearance of the test through an FDA emergency-use authorization.
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Shares of GenMark Diagnostics  (GNMK) - Get Report jumped after it said it had submitted a test for the coronavirus to the U.S. Food and Drug Administration for emergency-use authorization.

The test is called ePlex SARS-CoV-2. GenMark sent research-use-only tests to several key customers last week to validate the test using clinical samples.

GenMark used what it calls the ePlex platform "to quickly design and manufacture a test to accurately detect this highly contagious virus in clinical samples,” Chief Executive Scott Mendel said in a statement.

“Emergency-use authorization 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.”

The FDA is reviewing GenMark’s request, the company said. If the agency clears the test for marketing, the Carlsbad, Calif., company said it would begin shipping the test kits to customers for routine clinical use.

More than 121,000 people have contracted the coronavirus and more than 4,300 of them have died.

President Donald Trump on Tuesday indicated that on Wednesday he would introduce a package of fiscal-stimulus measures to counteract the impact of the coronavirus on the economy. 

He said those steps might include a payroll-tax cut, aid to workers who must stay home because of the virus, and assistance to industries hurt by the virus, such as travel and hospitality.

At last check, GenMark shares traded at $5.37, up 13%. They've traded up as much as 31% on Wednesday. The stock has dropped 22% over the past year, compared with a little-changed showing for the S&P 500 Index.