GenMark Achieves CE Mark for its ePlex® Blood Culture Identification Fungal Pathogen Panel
April 20 2017 - 4:31PM
Business Wire
Reports Positive Preliminary First Quarter
Revenues of $12.5 Million up 13% Versus Prior Year
Over 70 ePlex Customer Agreements Totaling
More than 100 Analyzers in Place at the End of First
Quarter
GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of
automated, multiplex molecular diagnostic testing systems, today
announced it has achieved CE Mark under the European In‐Vitro
Diagnostic Devices Directive (98/79/EC) for its ePlex Blood Culture
Identification Fungal Pathogen (BCID-FP) Panel. BCID-FP is the
first panel in the GenMark Sepsis Solution, which will also include
BCID Gram-Positive and Gram-Negative panels.
“We are very pleased to bring the first of our three blood
culture identification panels to the European market. Rapid
diagnosis of blood stream infections can have significant impact on
improving patient outcomes and reducing cost of therapy. GenMark’s
approach will enable this by providing the broadest pathogen
inclusivity and drug resistance markers of any multiplex molecular
solution on the market today,” said Hany Massarany, President and
Chief Executive Officer of GenMark.
“Fungal blood stream infections are some of the most critical
conditions we face in the clinical laboratory and diagnosing them
quickly and accurately has a significant positive impact on patient
outcomes. The ePlex Fungal Pathogen Panel brings rapid and
essential information regarding fungemia and its ease of use allows
a perfect integration in the routine workflow,” stated Dr. Danièle
Maubon, MD, PhD, of Grenoble Alpes University Hospital.
Information on the GenMark Sepsis Solution will be highlighted
at the 27th European Congress of Clinical Microbiology and
Infectious Diseases Meeting (ECCMID) in Vienna, Austria, from April
22-25, 2017, during conference poster sessions and a private
customer symposium.
The company also reported preliminary first quarter 2016 revenue
of $12.5 million, an increase of 13% over the prior year period. In
addition, the company announced that during the quarter, it added
more than 15 customer agreements. “First quarter revenue was in
line with our expectations and we continue to be very pleased with
the increasing customer interest in our ePlex sample-to-answer
system, particularly following our submissions to FDA last quarter.
We finished the first quarter with over 70 agreements totaling more
than 100 ePlex analyzers, many of which have already been installed
in end-user sites,” added Massarany.
ABOUT GENMARK DIAGNOSTICS
GenMark Diagnostics (NASDAQ: GNMK) GenMark Diagnostics 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 a compact, easy-to-use workstation 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.
SAFE HARBOR STATEMENT
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 our future financial
performance, the timely commercialization and regulatory clearance
of our ePlex system, and the availability of future financing, 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 commercialize 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170420006551/en/
GenMark Diagnostics, Inc.Hany Massarany,
760-448-4325President/Chief Executive Officer
GenMark Diagnostics (NASDAQ:GNMK)
Historical Stock Chart
From Aug 2024 to Sep 2024
GenMark Diagnostics (NASDAQ:GNMK)
Historical Stock Chart
From Sep 2023 to Sep 2024