March 20, 2020—The FDA has issued an emergency use authorization for GenMark Diagnostics’ ePlex SARS-CoV-2 Test. The test was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for patients suspected of COVID-19 and is for use on the company’s ePlex system, which provides results in less than two hours and can process up to 96 tests per eight-hour shift.
“Because ePlex enables near-patient testing and is available in hospitals and labs across the United States and in more than 30 countries, results can be returned to doctors and patients more rapidly than with other platforms,” Scott Mendel, interim chief executive officer of GenMark, said in a press statement. “Our unique ability to quickly diagnose and begin treatment of critically ill patients addresses the challenges associated with the coronavirus pandemic. The FDA’s emergency use authorization of our test supports GenMark’s commitment to provide critical and actionable diagnostic information to health care providers so that they can better manage their patients.”
GenMark is investing in additional manufacturing capacity with current capability to supply about 100,000 ePlex tests per month to support near-patient testing.