CARLSBAD, Calif.--(BUSINESS WIRE)--
GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of
automated, multiplex molecular diagnostic testing systems, today
announced that it has submitted 510(k) applications to the FDA for its
ePlex sample-to-answer instrument and Respiratory Pathogen Panel.
ePlex will offer comprehensive molecular diagnostic panels on a scalable
sample-to-answer system, designed to enable syndromic infectious disease
testing in hospital and reference laboratories. The system fully
integrates and automates the entire process from nucleic acid extraction
and amplification, through detection, interpretation and reporting.
Workflow has been optimized requiring approximately two minutes of
hands-on time and includes bi-directional integration to Laboratory
Information Systems (LIS), a patented technology for positive patient
identification, and the ability to provide customer support via remote
access. ePlex combines innovative digital microfluidics with GenMark's
eSensor® electrochemical detection technology, to enable
precise fluid management and accurate results. The ePlex Respiratory
Pathogen Panel is designed to detect the most clinically relevant viral
and bacterial targets from nasopharyngeal samples. The ePlex instrument
and Respiratory Pathogen Panel were launched in Europe in June, 2016.
"We designed ePlex to improve patient outcomes while optimizing
laboratory workflow and efficiency. Feedback from European customers and
U.S. clinical trial sites reinforces this unique value proposition of
ePlex," said Hany Massarany, President and Chief Executive Officer of
GenMark. "Our teams continue to focus on the global commercialization of
ePlex and the expansion of its menu. We expect our Blood Culture ID
family of panels, including the Gram Positive, Gram Negative, and Fungal
panels, to be available in Europe during the first quarter of 2017,"
ABOUT GENMARK DIAGNOSTICS
GenMark Diagnostics (NASDAQ: GNMK) is a leading provider of automated,
multiplex molecular diagnostic testing systems that detect and measure
DNA and RNA targets to diagnose disease and optimize patient treatment.
Utilizing GenMark's proprietary eSensor® detection
technology, GenMark's eSensor XT-8® system is designed to
support a broad range of molecular diagnostic tests with a compact,
easy-to-use workstation and self-contained, disposable test cartridges.
The eSensor detection technology is also incorporated into GenMark's
sample-to-answer system, ePlex®. 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 the timely FDA clearance and
commercialization of our ePlex instrument and its future test 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 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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