FDA Issues Emergency Authorization For ePlex SARS-CoV-2 Test

The US Food and Drug Administration (FDA) has issued Emergency Use Authorization for the ePlex SARS-CoV-2 test, produced by GenMark Diagnostics. The company announced the authorization Thursday, March 19.

The authorization comes as regulators seek to correct what has been perceived by some as a shortage of testing in the United States.

“Demand for our tests has been extraordinary, especially as centralized testing supply has been limited,” said Scott Mendel, Genmark’s Interim Chief Executive Officer.

The ePlex test detects SARS-CoV-2 RNA using nasopharyngeal swab samples. The test can only be used with the company’s ePlex system, which had a global coverage of over 500 analyzers as of December 31, 2019.

The test automates the diagnostic process, providing results in less than 2 hours. The system has the capacity to process up to 96 tests in an 8-hour period.

GenMark has provided over 10,000 tests since the beginning of March. The company intends to invest in additional manufacturing capability, according to their press release, and at present time has the capacity to provide about 100,000 ePlex tests per month.

The test is now authorized for use in qualified laboratories designated by the US Centers for Disease Control and Prevention (CDC).

Emergency Use Authorization allows unapproved products to be used in the context of a public health crisis. The FDA has previously granted Emergency Use Authorization to several other diagnostics, starting in early February with the CDC’s RT-PCR panel.

FDA also issued Emergency Use Authorization for the Cobas SARS-CoV-2 test, made by Roche, as well as Abbott’s RealTime molecular test.

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On March 25, 2020, at 6PM ET,

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