TUCSON, Ariz., Jan. 16, 2018 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (HTGM) (HTG), a provider of instruments, reagents and services for molecular profiling applications, today announced it has entered into a third statement of work for a new clinical assay development program under its Master Assay Development, Commercialization and Manufacturing Agreement with QIAGEN Manchester Limited, a wholly owned subsidiary of QIAGEN, N.V. (QGEN). Work for the new development program will begin immediately.
“We are very excited to initiate a third assay development program for yet another pharmaceutical company under our QIAGEN master agreement, which we believe further demonstrates the strength of our combined value proposition in the development of companion diagnostics,” said TJ Johnson, HTG’s President and CEO. “This new program has a very aggressive development timeline, including the possibility of a first regulatory filing in 2018.”
Headquartered in Tucson, Arizona, the mission of HTG is to empower precision medicine at the local level. The company’s HTG EdgeSeq technology, which automates highly multiplexed molecular profiling of small 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 regarding the anticipated benefits of, and activities expected to occur in connection with, the third development program under our master agreement with QIAGEN Manchester Limited (QIAGEN). 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 anticipated activities and/or regulatory filings under the third development program may not be performed as expected, or at all; the risk that the development work may not support the development, regulatory approval and/or commercialization of a diagnostic assay; 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; the ability of 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 September 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.
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HTG Molecular Diagnostics
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