TUCSON, Ariz., Jan. 05, 2017 (GLOBE NEWSWIRE) -- 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.”
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 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, 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.
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
HTG Molecular Diagnostics, Inc.