GenMark Diagnostics Inc. (NASDAQ: GNMK) stock shot up on Friday after the company announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the company’s ePlex SARS-CoV-2 test. Note that this is one of the fastest coronavirus tests out there, with a sizable capacity as well.
GenMark’s test was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for patients suspected of COVID-19 by their health care provider. The test is exclusively for use on the company’s ePlex system, which had a global installed base of more than 500 analyzers as of the end of 2019.
The ePlex sample-to-answer system provides an automated solution to the diagnostic process and provides results in under two hours with the capacity to process up to 96 tests per eight-hour shift.
Also, the ePlex system’s modular and expandable design enables near-patient COVID-19 testing to be widely accessible to meet the needs of various types of laboratories, from small decentralized sites to large central hospitals and laboratories.
Scott Mendel, interim CEO, commented:
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. Our unique ability to quickly diagnose and begin treatment of critically ill patients addresses the challenges associated with the coronavirus pandemic. We are proud of our team’s ability to rapidly respond to this urgent public health crisis. The FDA’s Emergency Use Authorization of our test supports GenMark’s commitment to provide critical and actionable diagnostic information to healthcare providers so that they can better manage their patients.
Shares of GenMark closed Thursday at $4.13, in a 52-week range of $3.36 to $8.17. The consensus price target is $9.75. Following the announcement, the stock was up about 54% at $6.35 in early trading indications Friday.
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