GenMark Announces Preliminary Q4 Financial Results and Initiation of ePlex™ Analytical Studies
January 12 2016 - 4:05PM
Business Wire
- Preliminary Fourth Quarter Revenue
Increased 35% Versus Prior Year to $13.2 Million
- XT-8 Installed Base Grew by 17 to
633
- Transfer to Manufacturing of ePlex
Sample-to-Answer System Completed and Analytical Studies
Commenced
GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading
provider of automated, multiplex molecular diagnostic testing
systems, today reported preliminary fourth quarter 2015 results.
The Company also announced that it has completed the transfer to
manufacturing of its ePlex system and initiated analytical studies
in support of European launch.
Preliminary fourth quarter 2015 revenue was $13.2 million, an
increase of 35% over the prior year period. Accordingly, the
Company expects full year 2015 revenue to be $39.4 million, an
increase of 29% versus 2014. During the quarter, 17 additional
XT-8 analyzers were placed in end-user laboratories, resulting in a
total installed base of 633 analyzers within the U.S. market. “We
drove a strong finish to the year in spite of a slower than
expected start to the flu season,” said Hany Massarany,
President and Chief Executive Officer of GenMark.
In addition, the Company commenced analytical studies of its
ePlex Respiratory Pathogen Panel. “Following the positive results
generated from initial internal and external studies and successful
transfer to manufacturing, we initiated analytical studies in
support of our upcoming European launch,” added Massarany. The
Company still expects a first quarter 2016 launch of ePlex in
Europe and 510(k) submission to the FDA in the second quarter of
2016.
The Company will present at the 2016 J.P. Morgan Healthcare
Conference to be held at the Westin St. Francis
Hotel in San Francisco, California on Wednesday,
January 13, 2016. The presentation will be delivered by Hany
Massarany, President and Chief Executive Officer, and is scheduled
to begin at 3:00 p.m. Pacific Time. The presentation will be
made available at http://ir.genmarkdx.com/. In addition, the Company
will be hosting a conference call to discuss fourth quarter results
in further detail and release 2016 guidance on Tuesday, February
23, 2016 starting at 4:30 p.m. Eastern Time. 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 21688003
approximately five minutes prior to the start time.
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 within
the meaning of the Private Securities Litigation Reform Act of
1995, Section 27A of the Securities Act of 1933, and Section 21E of
the Securities Exchange Act of 1934, 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 commercialization of our ePlex
system and our preliminary, unaudited 2015 financial performance,
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, our preliminary 2015
financial results are unaudited results based on management’s
current expectations and are subject to closing and year-end audit
adjustments; 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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version on businesswire.com: http://www.businesswire.com/news/home/20160112006369/en/
GenMark Diagnostics, Inc.Hany MassaranyPresident/Chief Executive
Officer760-448-4325
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