HTG Molecular Diagnostics, Inc. Provides Update Regarding Companion Diagnostic Development Programs

TUCSON, Ariz., Oct. 10, 2019 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. HTGM (HTG), a diagnostic company whose mission is to advance precision medicine, today provided an update regarding its ongoing efforts related to the development, manufacture and commercialization of companion diagnostic assays.

In November 2016, HTG entered into a Master Assay Development, Commercialization and Manufacturing Agreement with Qiagen Manchester Limited ("QML"), a wholly owned subsidiary of QIAGEN N.V. This master agreement was exclusive as to both HTG and QML in the field of oncology, and non-exclusive in all other fields. As previously disclosed, HTG expects the master agreement to become non-exclusive in the field of oncology at either HTG's or QML's election commencing November 16, 2019. As a result, HTG expects that:

• With respect to the two companion diagnostic programs that remain active under the master agreement, HTG will continue to abide by its existing obligations and complete all contracted work.
• Opportunities for the development of new RNA companion diagnostics that are based on the HTG EdgeSeq technology will be contracted directly by HTG with BioPharma customers. These new companion diagnostic opportunities are expected to leverage the existing HTG-Illumina Diagnostic Development Agreement, which has been in place since 2014 and continues to provide HTG with access to Illumina's diagnostic sequencers and associated sequencing chemistries.
• In the event that an HTG RNA companion diagnostic program reaches the point where global commercialization is required, HTG will be free to partner with any number of third parties, including possibly QML, with respect to distribution and other commercialization activities.

"We view this next phase of development as a natural transition in the evolution of our companion diagnostic efforts, particularly since all of the projects commenced to date under the QML master agreement have utilized Illumina's diagnostic sequencers and associated chemistries," said John Lubniewski, President and CEO of HTG. "We look forward to having greater direct control over our RNA companion diagnostic opportunities, while maintaining flexibility as it relates to global commercialization once a program reaches that stage."

About HTG:

HTG is focused on 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. The company's 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 HTG's expectations with respect to its master agreement with QML, including the expected transition to a non-exclusive relationship with QML in the field of oncology and the potential benefits to HTG resulting therefrom, and the expectation that new companion diagnostic opportunities will leverage the existing HTG-Illumina Diagnostic Development Agreement. 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 we may not be able to contract directly with BioPharma customers for the development of new RNA companion diagnostics on favorable terms, or at all; the risk that we may not be able to leverage the existing HTG-Illumina Diagnostic Development Agreement in the development of new companion diagnostics; 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 third 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 third 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, 2019. 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 R. Robinson LifeSci Advisors, LLC
Phone: (617) 535-7742
Email: arr@lifesciadvisors.com

Source: HTG Molecular Diagnostics, Inc