GenMark Awarded BARDA Grant for the Development of ePlex® RP2 Panel
24 März 2020 - 12:45AM
GenMark Diagnostics, Inc. (NASDAQ:GNMK), a leading provider of
automated, multiplex molecular diagnostic testing systems, today
announced it has been awarded a grant from the Biomedical Advanced
Research and Development Authority (BARDA), part of the Department
of Health and Human Services (HHS) Office of the Assistant
Secretary for Preparedness and Response (ASPR).
In working with public and private partners to find solutions to
mitigate the impact of COVID-19, BARDA will provide GenMark with up
to $749,000 in funding to develop and pursue U.S. Food and Drug
Administration (FDA) Emergency Use Authorization (EUA) of a
diagnostic panel that incorporates the new SARS-CoV-2 viral target
into the company’s existing ePlex Respiratory Pathogen (RP) panel.
With this additional support from BARDA, GenMark expects to be able
to complete the development work necessary to request an EUA from
the FDA for the ePlex RP2 Panel.
GenMark’s ePlex RP2 Panel will leverage the company’s ePlex
instrument that has been FDA cleared for use with its ePlex
Respiratory Pathogen (RP) Panel, Blood Culture Identification
(BCID) Panels (Gram-positive, Gram-negative and Fungal pathogens),
and most recently the Emergency Use Authorization of a SARS-CoV-2
Test. The FDA has categorized the ePlex system and tests as
Clinical Laboratory Improvement Amendments (CLIA) moderately
complex, allowing for its use in a broad array of hospital and
reference lab settings. The new test will be developed for
the qualitative detection of respiratory pathogens in
nasopharyngeal swab samples. The addition of the SARS-CoV-2 target
to the existing ePlex RP Panel will allow for rapid, streamlined
testing for respiratory illnesses, saving time and valuable
hospital resources that are critically limited at this time.
Recent evidence shows a high percent of COVID-19 patients are also
infected with other respiratory viruses, making it even more
important to test for a broad panel of respiratory pathogens.
“We are very honored to receive this support from BARDA to
continue the development of our ePlex RP2 Panel,” said Scott
Mendel, Interim Chief Executive Officer. “Providing a single test
with comprehensive, rapid and actionable results across a broad
range of viral and bacterial pathogens enables improved patient
outcomes. Our team fully understands the urgency to develop
this expanded RP panel and we will work hard to deliver exactly
that.”
About GenMark DiagnosticsGenMark Diagnostics
(NASDAQ: GNMK) is a leading provider of multiplex molecular
diagnostic solutions designed to enhance patient care, improve key
quality metrics, and reduce the total cost-of-care. Utilizing
GenMark's proprietary eSensor® detection technology, GenMark's
eSensor XT-8® and ePlex® systems are designed to support a broad
range of molecular diagnostic tests with compact, easy-to-use
workstations and self-contained, disposable test cartridges.
GenMark’s ePlex: The True Sample-to-Answer Solution™ is designed to
optimize laboratory efficiency and address a broad range of
infectious disease testing needs, including respiratory,
bloodstream, and gastrointestinal infections. For more
information, visit www.genmarkdx.com.
Forward Looking StatementsThis 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
successfully develop and obtain an EUA from the FDA for our ePlex
RP2 Panel, 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.
Investor Relations ContactLeigh Salvo(415)
937-5404ir@genmarkdx.com
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