GenMark Achieves CE Mark for its ePlex® Blood Culture Identification Gram-Positive and Gram-Negative Panels
June 29 2017 - 4:30PM
Business Wire
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 Gram-Positive (BCID-GP) Panel and its Blood Culture
Identification Gram-Negative (BCID-GN) Panel. BCID-GP and BCID-GN
complete the ePlex family of sepsis panels, which also includes the
BCID Fungal Pathogen (BCID-FP) Panel that achieved CE Mark in April
2017.
“We are very pleased to bring these additional Blood Culture
Identification (BCID) panels to the European market. This rounds
out our family of ePlex blood stream infection assays, which we’ve
designed to offer 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. “Based on multiple internal and external
studies, we are very pleased with the performance of all three
ePlex BCID panels, which we believe will have a significant impact
on the management of a critical disease state, while bringing
clinical, economic, and quality benefits to ePlex customers and
their patients,” added Massarany.
"Sepsis resulting from blood stream infection has a high
mortality rate and is one of the most expensive conditions managed
in the hospital. Rapid, accurate, and easy-to-use diagnostics are
needed to ensure timely pathogen identification and to inform
appropriate therapy selection,” stated Prof. Brigitte K�nig,
Institute of Medical Microbiology and Infectious Diseases, Leipzig
University. “The ePlex BCID solution, with Gram-Positive,
Gram-Negative, and Fungal Pathogen Panels, provides the broadest
pathogen and resistance gene coverage of available rapid molecular
tests while also being simple enough to perform 24/7, ensuring
physicians receive lab results as quickly as possible and helping
to improve outcomes for critical sepsis patients.”
The Company plans to release its second quarter earnings results
on Tuesday, August 1, 2017. Management will hold a conference call
to review the Company's financial performance starting at 8:30 a.m.
ET on the same day. The conference call will be concurrently
webcast. The link to the webcast will be available on the GenMark
Diagnostics, Inc. website at www.genmarkdx.com under the investor
relations section and will be archived for future reference. To
listen to the conference call, please dial (877) 312-5847
(US/Canada) or (253) 237-1154 (International) and use the
conference ID number 48903152 approximately five minutes prior to
the start time.
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 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 and the clinical, economic and quality impacts of new
products, 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/20170629006300/en/
GenMark Diagnostics, Inc.Hany MassaranyPresident/Chief Executive
Officer760-448-4325
GenMark Diagnostics (NASDAQ:GNMK)
Historical Stock Chart
From Apr 2024 to May 2024
GenMark Diagnostics (NASDAQ:GNMK)
Historical Stock Chart
From May 2023 to May 2024