GenMark Receives FDA Emergency Use Authorization for its ePlex® SARS-CoV-2 Test
COVID-19 diagnosis in under two hours now available globally in hospitals on company’s ePlex System
Unique sample-to-answer capability enables near patient testing for the most critical patient populations
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. Rapid and easy detection of SARS-CoV-2 is becoming increasingly critical and customers are adopting the ePlex test based on the workflow and ease-of use to address this urgent need. 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
“Because ePlex enables near-patient testing and is available in hospitals and labs across
Initial customer validations of the ePlex® SARS-CoV-2 (RUO) Test were met with positive laboratory customer feedback, including from both existing customers and new sites. GenMark is one of the first companies to commercialize a rapid sample-to-answer test to help meet the critical testing need during this public health crisis and has provided nearly ten thousand tests to customers since the beginning of March.
“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
GenMark is continuing to invest in additional manufacturing capacity with current capability to supply approximately 100,000 ePlex tests per month to support near patient testing. “Demand for our tests has been extraordinary, especially as centralized testing supply has been limited. 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,” concluded Mendel.
About ePlex SARS-CoV-2 Test
The ePlex SARS-CoV-2 Test can be used to test nasopharyngeal swab (NPS) specimens. The ePlex SARS-CoV-2 Test should be ordered for the qualitative detection of SARS-CoV-2 in individuals suspected of COVID-19 by their health provider. The ePlex SARS-CoV-2 Test is authorized for use in qualified laboratories designated by
About Emergency Use Authorization Status
The GenMark ePlex SARS-CoV-2 Test has been made available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the use of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA approved or cleared IVD. However, based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of COVID-19. The EUA for this test is in effect for the duration of the COVID-19 emergency, unless terminated or revoked (after which the test may no longer be used). An FDA approved or cleared IVD should be used instead of an IVD under EUA, when applicable and available.
Forward Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, our ability to successfully obtain full IVD clearance of our ePlex SARS-CoV-2 Test from the FDA and demonstrate its clinical performance and utility, the continued progression of the associated public health emergency, our ability to satisfy the supply demands of our customers, and other risks and uncertainties described under the "Risk Factors" in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
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Source: GenMark Diagnostics, Inc.