GenMark Receives FDA Emergency Use Authorization for its ePlex SARS-CoV-2 Test - Seite 2

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 David T. Pride, MD, PhD, director of the Clinical Molecular Microbiology Laboratory and associate director of the Microbiology Laboratory at UC San Diego Health. “We completed the validation and were the first lab in the U.S. to go live with the ePlex test.”

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 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.