CARLSBAD, Calif.--(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 König, 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.
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GenMark Diagnostics, Inc.
Source: GenMark Diagnostics, Inc.
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