GenMark Diagnostics Inc (NASDAQ:GNMK) stock surged Friday after the company received Emergency Use Authorization from the US Food and Drug Administration for its ePlex SARS-CoV-2 coronavirus (COVID-19) test.
The company’s coronavirus test consists of a nasopharyngeal swab (the upper throat, done through the nose) and can deliver results within two hours while processing 96 tests per eight hour hospital shift. The test is built on the company’s ePlex diagnostic system, which has a global base of more than 500 analyzers.
GenMark shares traded 47% higher at $6.10 Friday morning.
The ePlex system is already in place in hospitals and labs around the world, the company said, so doctors can implement its coronavirus test quickly.
“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,” Interim CEO Scott Mendel said. “Our unique ability to quickly diagnose and begin treatment of critically ill patients addresses the challenges associated with the coronavirus pandemic.
GenMark’s test has already received positive feedback, both from existing customers and new sites.
“GenMark reached out to us several weeks ago to ask for our help to run the first patient samples on their RUO ePlex SARS-CoV-2 Test,” said David Pride, director of the Clinical Molecular Microbiology Laboratory at UC San Diego Health. “We completed the validation and were the first lab in the US to go live with the ePlex test.”
The Carlsbad, California-based company said it’s continuing to invest in boosting its manufacturing rate of roughly 100,000 ePlex tests per month.
“Demand for our tests has been extraordinary, especially as centralized testing supply has been limited,” Mendel said. “Our team is working 24/7 to fight this global pandemic, and we are taking every step possible to continue this pace, including consulting with local, state and federal agencies.
“The COVID-19 outbreak highlights the value of rapid, near-patient multiplex molecular diagnostics to the global healthcare ecosystem that enables better patient triage, bed management, and patient care decisions,” he added.
Contact Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel