UPDATE – HTG Molecular Diagnostics and Merck KGaA, Darmstadt, Germany, Enter Into a Master Companion Diagnostics Agreement

TUCSON, Ariz., Oct. 11, 2016 - HTG Molecular Diagnostics, Inc. (HTGM) (“HTG”), a provider of instruments and reagents for molecular profiling applications, and Merck KGaA, Darmstadt, Germany, have entered a broad companion diagnostics master agreement. The initial development program agreement utilizes the HTG EdgeSeq DLBCL Cell of Origin Assay in the Merck KGaA, Darmstadt, Germany, M7583, selective and irreversible inhibitor of Bruton’s Tyrosine Kinase (BTK), program.

 

“We are honored to be chosen as the diagnostic development partner for Merck KGaA’s BTK program and our team is now focused on the near-term milestones.  Additionally, having a master companion diagnostic agreement paves the way for additional development collaborations,” stated TJ Johnson, HTG’s President and CEO.  “We have worked very hard to establish the organizational capabilities to support the development, regulatory filing and commercialization of companion diagnostics demonstrated by the recent CE/IVD marking of HTG’s DLBCL cell of origin assay,” added Mr. Johnson.

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 our agreement with Merck KGaA, and our ability to support the development, regulatory filing and commercialization of companion diagnostics. 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 we may not realize the expected benefits from our agreement with Merck KGaA, 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 June 30, 2016. 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.