HTG Molecular Diagnostics Completes Module Three Filing for HTG EdgeSeq ALKPlus Assay PMA
January 05 2017 - 4:01PM
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM) (“HTG”), a provider
of instruments and reagents for molecular profiling applications,
today announced that it has submitted to the FDA the third of four
expected modules for the Company’s Pre-Market Approval (PMA)
application for the HTG EdgeSeq ALKPlus Assay to be used as a
companion diagnostic for Crizotinib.
The third PMA module included data from analytical performance
studies completed at HTG along with inter-lab reproducibility study
data completed at three trial sites.
“We are very pleased to meet this milestone for the HTG EdgeSeq
ALKPlus Assay PMA submission,” stated TJ Johnson, President and CEO
of HTG Molecular Diagnostics. “This module three submission
was a significant undertaking for the HTG team, and we are now
fully focused on completing the fourth and final PMA module early
in 2017.”
About HTG:
Headquartered in Tucson, Arizona, HTG’s mission is to empower
precision medicine at the local level. In 2013 the company
commercialized its HTG Edge instrument platform and a portfolio of
RNA assays that leverage HTG's proprietary nuclease protection
chemistry. HTG’s product offerings have since expanded to include
its 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 related to planned FDA submissions.
Words such as "believes," "anticipates," "plans," "expects,"
"intends," "will," "goal," "potential" and similar expressions are
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forward-looking statements necessarily contain these identifying
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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, the risk that FDA submissions may
not be completed when expected, if at all, and risks associated
with the process of developing and commercializing oncology
applications and biomarker panels. 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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