GenMark Diagnostics Files For Emergency Use Authorization For COVID-19 Test
GenMark Diagnostics, Inc (GNMK) shares are headed higher again following an update from the company regarding its COVID-19 diagnostics test.
The company said it has submitted an Emergency Use Authorization, or EUA, to the FDA for its ePlex SARS-CoV-2 Test. Once the EUA is granted, the test could be used by clinical labs for detecting COVID-19.
The company said initial Research Use Only, or RUO, tests were shipped last week to several key customers to validate the assay design using clinical samples.
"EUA submission in just over a week from the initial RUO 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," said Scott Mendel, interim CEO of GenMark.
Several diagnostics companies have jumped into the fray to develop or distribute tests to diagnose the virus. Tuesday, Aytu Bioscience Inc (AYTU) skyrocketed close to 500% on a COVID-19 test distribution deal.
GenMark shares were trading higher by 7.3% to $5.10 at time of publication.
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