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HTG Molecular Diagnostics Announces Second Companion Diagnostic Development Project with QIAGEN
Developing NGS Gene Expression Profiling Assays for Multiple Cancer Therapies

TUCSON, Ariz. and VENLO, the Netherlands, July 27, 2017 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM) (“HTG”), a provider of instruments, reagents and services for molecular profiling applications today announced the initiation of a second development program under the company’s Master Assay Development, Commercialization and Manufacturing Agreement (“Master Agreement”) with QIAGEN Manchester Limited, a wholly owned subsidiary of QIAGEN N.V. (NASDAQ:QGEN) (Frankfurt Stock Exchange:QIA) (“QIAGEN”). HTG EdgeSeq technology will be used in the program to develop gene expression profiling (“GEP”) assays for use with next-generation sequencing (“NGS”) technology in support of another pharmaceutical company’s therapeutic development and commercialization programs.

This new development program follows the announcement by HTG of the first statement of work under the Master Agreement and the recent announcement by QIAGEN that it has signed a new master collaboration agreement with Bristol-Myers Squibb to explore the use of NGS technologies to develop GEP assays for use with Bristol‑Myers Squibb’s immuno-oncology therapies.

“We are very pleased with the early results of our partnership with QIAGEN and are encouraged by customer reception to our joint capabilities, which provide a complete NGS solution from biomarker development to full companion diagnostic commercialization,” said TJ Johnson, President and Chief Executive Officer of HTG. “With two new programs realized from the QIAGEN partnership to date, HTG now has three distinct clinical assay development programs underway, including two that we believe could lead to regulatory filings for companion diagnostics during 2018. These programs are expected to provide meaningful short-term program revenues, but also potential reoccurring revenues if the applicable drugs are approved for use with a companion diagnostic assay.”

“We believe the commencement of a second companion diagnostic program under the Master Agreement within a short time clearly demonstrates how strongly pharma views the anticipated combination of HTG EdgeSeq technology with QIAGEN’s GeneReader NGS system,” said Thierry Bernard, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN.

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 associated with the anticipated benefits of, and activities expected to occur in connection with, the second development project under our Master Agreement. 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 the activities initiated under the second development project may not be performed as expected, or at all, the risk that a formal statement of work regarding the development project may not be executed, the risk that the development work may not support the development and commercialization of a diagnostic assay, risks associated with the utility of our automation systems, proprietary profiling panels and solutions, and our ability to successfully manufacture and supply our products. 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 March 31, 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.

HTG Contacts: 
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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HTG Molecular Diagnostics, Inc.

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