HTG Molecular Diagnostics Obtains CE Mark for its HTG EdgeSeq ALKPlus Assay EU
March 22 2017 - 4:01PM
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of
instruments, reagents, and services for molecular profiling
applications, today announced that it has obtained CE marking in
the European Union for its HTG EdgeSeq ALKPlus Assay EU.
The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay
intended to measure and analyze mRNA ALK gene rearrangements in
formalin-fixed, paraffin-embedded lung tumor specimens from
patients previously diagnosed with non-small cell lung cancer
(NSCLC). The assay may be used to aid in the identification of
patients eligible for treatment with ALK-targeted therapeutics,
such as crizotinib, and is automated on the HTG EdgeSeq system
using a next-generation sequencer for detection.
Lung cancer is a leading cause of cancer death in men and women
worldwide. In Europe, approximately 391,000 people were diagnosed
with lung cancer in a single year, according to the European
Society for Medical Oncology, and NSCLC accounts for 85 to 90% of
all lung cancer cases. Due to the important therapeutic
implications, routine testing for rearrangement in the ALK gene is
now recommended for all NSCLC patients diagnosed with
adenocarcinoma.
"We are pleased to add the HTG EdgeSeq ALKPlus Assay EU to our
diagnostic assay menu in Europe,” stated TJ Johnson, HTG’s
President and CEO. “Lung cancer is a significant global health
problem and an important focus area for HTG. We plan to offer this
assay to selected European early adopters as we seek additional
regulatory approvals elsewhere.”
About HTG:
Headquartered in Tucson, Arizona, the mission of HTG Molecular
Diagnostics, Inc. (HTG) is to empower precision medicine at the
local level. In 2013, the company commercialized its first
instrument platform and a portfolio of RNA assays that leveraged
HTG's original proprietary nuclease protection chemistry.
Continuous improvement led to the 2014 launch of the company’s HTG
EdgeSeq product line, which automates sample and targeted library
preparation for next-generation sequencing. Additional information
is available at www.htgmolecular.com.
Safe Harbor Statement:
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements associated with our business and the
capabilities of our technology, the benefits and uses of our HTG
EdgeSeq ALKPlus Assay EU, and the European lung cancer market size
and testing standards of care. Words such as "believes,"
"anticipates," "plans," "expects," "intends," "will," "goal,"
"potential" and similar expressions are intended to identify
forward-looking statements, though not all forward-looking
statements necessarily contain these identifying words. These
forward-looking statements are based upon management's current
expectations, are subject to known and unknown risks, and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties,
including, without limitation, risks associated with our ability to
successfully develop, market and/or commercialize new methods,
technologies and/or products, including our ability to market, sell
and maintain or obtain regulatory approvals for our HTG EdgeSeq
ALKPlus Assay EU in Europe or other jurisdications. These and other
factors are described in greater detail in our filings with the
Securities and Exchange Commission, including without limitation
our Quarterly Report on Form 10-Q for the Quarter ended September
30, 2016. All forward-looking statements contained in this press
release speak only as of the date on which they were made, and we
undertake no obligation to update such statements to reflect events
that occur or circumstances that exist after the date on which they
were made.
Contact:
Westwicke Partners
Jamar Ismail
Phone: 415-513-1282
Email: jamar.ismail@westwicke.com
TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: tjjohnson@htgmolecular.com
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