GenMark Diagnostics Submits 510(k) Applications to the FDA for ePlex® Sample-to-Answer Instrument & Respiratory Pathogen Panel
December 22 2016 - 8:05AM
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,” added
Massarany.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161222005114/en/
GenMark Diagnostics, Inc.Hany MassaranyPresident/Chief Executive
Officer760-448-4325
GenMark Diagnostics (NASDAQ:GNMK)
Historical Stock Chart
From Mar 2024 to Apr 2024
GenMark Diagnostics (NASDAQ:GNMK)
Historical Stock Chart
From Apr 2023 to Apr 2024