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HTG Molecular Diagnostics Fulfills First Orders for its Next-Generation Sequencing-Based HTG EdgeSeq Precision Immuno-Oncology Panel

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TUCSON, Ariz., Aug. 15, 2018 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) (HTG), a provider of instruments, reagents, and services for molecular profiling applications, today announced it launched its HTG EdgeSeq Precision Immuno-Oncology Panel and has delivered its first orders to translational and clinical researchers working in the field of cancer immunology and/or cancer immunotherapy. This Research Use Only profiling panel provides a large, comprehensive set of genes involved in the host immune response to tumors.

"We are thrilled to offer this comprehensive RUO panel. While progress has been made in immuno-therapies, much work still remains on biomarker development to better identify patients who will respond or not respond to these therapies, and we believe our panel, with its 1,392 genes will go a long way in helping reach that goal," said Mike Hrubiak, Senior Vice President of HTG's Profiling Business Unit. "We designed this comprehensive assay with input from our scientific advisory panel to further explore areas of immuno-oncology research, including immunophenotyping, tumor inflammation status, and immune-resistance pathways."

The ability to characterize immune response in tumor environments is believed to be key to developing strategies in recruiting the body's immune system to recognize and respond to the cancer cells. By using the HTG EdgeSeq Precision Immuno-Oncology Panel, researchers can go from raw sample to sequencing-ready libraries in as little as 36 hours, with less than four hours of hands-on time. HTG is also developing analytic modules to provide researchers with the answers they need when they need them and to provide labs with a complete solution to empower precision medicine at the local level.

About the HTG EdgeSeq Precision Immuno-Oncology Panel

The HTG EdgeSeq Precision Immuno-Oncology Panel includes applications such as the immunophenotyping of tumor infiltrating lymphocytes (TILs); monitoring of immunotherapy response biomarkers; and the elucidation of immune-escape mechanisms known to drive disease progression. Using only a single 5 µm formalin-fixed, paraffin-embedded (FFPE) tissue section, the panel profiles 1,392 genes, without the RNA extraction and complex workflow associated with standard RNA-seq methods. Together with the HTG EdgeSeq system, users will have the ability to profile using a wide variety of sample types allowing them to accelerate discovery, support translational applications, and determine potential biomarkers for development of companion diagnostics.

About HTG:

HTG is focused on next generation sequencing (NGS) based molecular profiling. The company's proprietary HTG EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG's customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries, and ultimately to identify treatment options. Our mission is to empower precision medicine at the local level.

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 regarding the design, expected features and functionality of the HTG EdgeSeq Precision Immuno-Oncology Panel. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements, although 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 the HTG EdgeSeq Precision Immuno-Oncology Panel may not function or provide benefits to our customers as expected, risks associated with our ability to successfully commercialize our products; the risk that our products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all; our ability to manufacture our products to meet demand; the level and availability of first party payor reimbursement for our products; our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of first parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. 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, 2018. 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
Phone: (617) 525-7754
Email: arr@lifesciadvisors.com

TJ Johnson
Chief Executive Officer
HTG Molecular Diagnostics
Phone: (520) 547-2827 x130
Email: tjjohnson@htgmolecular.com

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