HTG Molecular Diagnostics Provides Regulatory Update for its HTG EdgeSeq ALKPlus Assay

Company Intends to Submit Fourth and Final Module for PMA in Second Quarter of 2018

TUCSON, Ariz., Sept. 11, 2017 -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents and services for molecular profiling applications, today announced that it expects to complete and file the fourth and final module related to the premarket approval application (PMA) submission for its HTG EdgeSeq ALKPlus Assay in the second quarter of 2018. The first three modules of the PMA have already been submitted to the U.S. Food and Drug Administration (FDA) for review.

“To date, the FDA has completed its review of the first two of the three submitted modules and is currently reviewing the third module,” said TJ Johnson, Chief Executive Officer of HTG. “Following collaborative discussions with FDA, we have finalized plans to conduct a method comparison study needed to complete and file the fourth and final module. We anticipate completing this study in the first quarter of 2018 and submitting the final PMA module in the second quarter of 2018. Importantly, we believe our commercialization efforts with the HTG EdgeSeq ALKPlus Assay EU, our CE/IVD marked product in Europe, are going well, and we intend to launch the HTG EdgeSeq ALKPlus Assay in the U.S. once we receive PMA approval.”

The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic 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). This assay may be used to aid the identification of patients eligible for ALK-targeted therapeutics, such as crizotinib, and is automated on the HTG EdgeSeq system using a next-generation sequencer for detection.  

About HTG:
Headquartered in Tucson, Arizona, the mission of HTG Molecular Diagnostics (HTG) is to empower precision medicine at the local level. The company’s HTG EdgeSeq technology, which automates highly multi-plexed molecular profiling of minute samples for next-generation sequencing, received its first US patent in 2014. Continuous improvements led to the 2017 launch of HTG’s new direct-target sequencing chemistry for DNA analysis offered in the company’s VERI/O services laboratory. 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 about the timing of filing the fourth module of our HTG EdgeSeq ALKPlus Assay PMA and the benefits and uses of our HTG EdgeSeq ALKPlus Assay EU. 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 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 our HTG EdgeSeq ALKPlus Assay in the U.S. 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 June 30, 2017. 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:
Ashley Robinson
LifeSci Advisors, LLC
617-775-5956
[email protected]

TJ Johnson
President/CEO
HTG Molecular Diagnostics
520-547-2827 x130
[email protected]