GenMark Diagnostics Announces Submission of Emergency Use Authorization for its eSensor SARS-CoV-2 Test
Leveraging GenMark’s eSensor XT-8 platform to expand COVID-19 diagnostic testing capacity
CARLSBAD, Calif., Aug. 17, 2020 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (NASDAQ: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, announced that it has
notified the U.S. Food and Drug Administration (FDA) of the intent to commercially distribute the eSensor SARS-CoV-2 Test for clinical use. The company has also submitted an Emergency Use
Authorization (EUA) to the FDA for its eSensor SARS-CoV-2 Test.
The eSensor SARS-CoV-2 test utilizes the design principles of GenMark’s eSensor Respiratory Viral Panel (RVP), which has been recognized as one of the most sensitive RVP assays available1. The eSensor SARS-CoV-2 Test consists of PCR amplification and detection reagents and eSensor SARS-CoV-2 test cartridges which run on GenMark’s XT-8 System. The XT-8 is GenMark’s legacy multiplex molecular diagnostic system.
“We developed this product and submitted the EUA to leverage our available eSensor test capacity and XT-8 installed base to further help with addressing COVID-19 testing demands,” said Scott Mendel, President and CEO of GenMark. “The COVID-19 testing approach for some institutions is better aligned to large batch-based testing for which the eSensor XT-8 workflow is well suited. This provides our over 100 customers still using the eSensor XT-8 system an opportunity to expand their COVID-19 testing capabilities.”
The eSensor SARS-CoV-2 Test can provide results for 96 samples in 5 hours. Core labs in the hospital and reference labs have the expertise, equipment and workflow to accommodate 96-well plate processing of clinical specimens and with four batched runs can process 384 specimens per day.
Upon completion of the FDA notification process, GenMark’s eSensor SARS-CoV-2 Test is commercially available while under EUA review by the FDA. GenMark earlier this year announced the launch of its ePlex SARS-CoV-2 Test and the ePlex Respiratory Pathogen Panel 2 (RP2), which detects 21 pathogens, including SARS-CoV-2, both of which run on the Company’s sample-to-answer ePlex System.
About Emergency Use Authorization Status
The GenMark eSensor SARS-CoV-2 Test will be 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 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 cleared IVD should be used instead of an IVD under EUA, when applicable and available.