TUCSON, Ariz., Feb. 20, 2019 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (HTGM) (HTG), a diagnostic company whose mission is to advance precision medicine, today announced it has amended its second precision diagnostic partnership program (“PDP Two”) with QIAGEN Manchester Limited (QML) originally signed in October 2017. This fourth amendment to the program extends the use of the investigational use only (IUO) assay previously developed as part of the program, and adds certain activities that potentially could be included in future companion diagnostic regulatory submissions. The program amendment is expected to generate revenue in the low single-digit millions for these additional activities. HTG expects to complete the activities related to this amendment in 2019.
“This amendment highlights the expanded utilization of the program assay into additional trials as well as activities getting us closer to a potential companion diagnostic,” stated Byron Lawson, HTG’s SVP of Pharma Partnerships. “We are very appreciative of the trust our Pharma partner has extended us with this expansion,” Mr. Lawson continued.
John Lubniewski, HTG’s President and COO, added, “Becoming a preferred partner with biopharmaceutical companies in biomarker-driven drug development is a key aspect of our strategy. I am proud of our program team and the commitment to customer satisfaction that they continually demonstrate.”
HTG is focused on advancing precision medicine. 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.
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 or outcomes of PDP Two. 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 PDP Two, as amended, may not be performed as expected, or at all, the risk that the work to be performed under PDP 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 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 September 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.
Ashley R. Robinson
LifeSci Advisors, LLC
Phone: (617) 535-7742