GenMark Diagnostics Announces FDA Submission of its ePlex Blood Culture Identification Gram Positive Panel
June 28 2018 - 4:57PM
GenMark Diagnostics, Inc. (NASDAQ:GNMK), a leading provider of
automated, multiplex molecular diagnostic testing systems, today
announced submission of its ePlex Blood Culture ID – Gram Positive
(BCID-GP) panel to the U.S. Food and Drug Administration
(FDA). The BCID-GP panel is the first of three blood culture
panels being developed on the ePlex sample-to-answer system, for
the diagnosis and disease management of bloodstream infections that
can lead to sepsis. The Company anticipates FDA submission of the
Gram Negative panel (BCID-GN) and the Fungal Pathogen panel
(BCID-FP) in the third and fourth quarters of this year, consistent
with prior communication.
“The FDA submission of our ePlex BCID-GP panel marks an
important milestone for GenMark, as we continue to expand our menu
of multiplex molecular panels across multiple infectious
diseases. We designed the ePlex BCID-GP panel to offer the
broadest pathogen inclusivity and drug resistance markers of any
multiplex molecular solution on the market today and believe it
will meaningfully improve the management of patients with blood
stream infections and provide a new tool to help address the
growing public health crisis of antibiotic resistance,” said Hany
Massarany, President and Chief Executive Officer.
“We’ve also recently initiated the clinical study for our
BCID-GN panel and we’re in the final stages of preparation for the
BCID-FP clinical study. Based on this, we continue to expect
to submit these panels to FDA later this year,” noted
Massarany.
About GenMark Diagnostics GenMark 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 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,
including, but not limited to, those regarding the timely FDA
clearance and commercialization of additional ePlex panel menu, are
all 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 regulatory clearance in the United
States for our ePlex BCID panels, the commercialization our
ePlex system and its related test menu in a timely manner,
constraints or inefficiencies caused by unanticipated acceleration
and deceleration of customer demand, our ability to successfully
expand sales of our product offerings outside the United States,
and third-party payor reimbursement to our customers, as well as
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 ContactLynn Pieper Lewis or
Leigh Salvo(415) 937-5404ir@genmarkdx.com
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