GenMark Diagnostics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company’s ePlex SARS-CoV-2 Test. 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 December 31, 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 8-hour shift. 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.
“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,” said Scott Mendel, Interim Chief Executive Officer. “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.”
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 CDC and in the U.S., certified under CLIA to perform high complexity tests. A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 (formerly 2019-nCoV) was detected, and the patient is presumptively infected with COVID-19 and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines. All laboratories using this test must follow the standard confirmatory testing and reporting guidelines according to their appropriate public health authorities. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing should be considered in consultation with public health authorities.