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TUCSON, Ariz., Aug. 09, 2018 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a provider of instruments, reagents, and services for molecular profiling applications, today announced that it has entered into an amendment to the second statement of work (“SOW Two”) under its Master Assay Development, Commercialization and Manufacturing Agreement with Qiagen Manchester Limited (“QML”). SOW Two relates to a project for which HTG and QML are performing collaborative development services for what is expected to be a multi-stage project leading to the potential development and commercialization of an NGS-based companion diagnostic assay in support of one or more of the therapeutic development and commercialization programs of Bristol-Myers Squibb Company (“BMS”). Initial-phase development activities under SOW Two are complete and the amendment relates to the next phase which includes the use of the investigational use only assay in a retrospective clinical trial.
“We are very pleased to continue our immuno-oncology collaboration with QML and BMS as we move into the first developed assay’s use in a retrospective clinical trial,” said TJ Johnson, Chief Executive Officer. “We expect this to be the first of additional project amendments to SOW Two, which could potentially lead to the use of the assay in subsequent clinical trials and to the commercialization of companion diagnostics.”
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 activities expected to occur in connection with the amendment to SOW Two with QML. 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 activities contemplated by SOW Two, as amended, may not be performed as expected, or at all, the risk that the work to be performed under SOW Two, as amended, may not support additional clinical trials or the development and commercialization of a companion 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; 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 March 31, 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.
LifeSci Advisors, LLC
Phone: (617) 525-7754
Chief Executive Officer
HTG Molecular Diagnostics
Phone: (520) 547-2827 x130