HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) Files An 8-K Other EventsItem 8.01
On April 17, 2017, we announced in a press release that we have entered into a master services agreement with Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) for work to be performed in our VERI/O laboratory. The initial project includes the development of a custom assay for the detection of nearly 3,000 mRNA targets using our HTG EdgeSeq technology.
When completed, the custom assay will be used to generate data from formalin-fixed, paraffin-embedded (“FFPE”) samples. Daiichi Sankyo plans to use these data to identify a tumor profiling assay for future studies under the agreement. Daiichi Sankyo also has engaged us to process several hundred FFPE samples using the HTG EdgeSeq ALKPlus Assay EU in a research use only mode for exploratory research on new, potential therapeutic biomarkers.
On April 17, 2017, we also announced in a press release that we have entered into a research agreement with Centre Léon Bérard, which provides the framework for molecular profiling studies aimed to advance precision medicine. The initial project utilizes our HTG EdgeSeq Oncology Biomarker Panel to retrospectively characterize immunologic profiles from advanced malignant tumor samples collected in the ProfiLER study (ClinicalTrials.gov identifier NCT01774409).
Forward Looking Statements
Statements contained in this report 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 about the anticipated benefits or outcomes of our agreement with Daiichi Sankyo, the anticipated benefits or results of our agreement with Centre Léon Bérard, the capabilities of our technology and our ability to successfully develop custom assays, advance precision medicine with our research partners or otherwise, and develop, market and commercialize companion diagnostic assays. 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, risks associated with the process of developing, marketing and commercializing our products, our ability to achieve and sustain sufficient market acceptance, and the capabilities of our product and service solutions to keep pace with rapidly changing technology and customer requirements. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Annual Report on Form 10-K for the year ended December 31, 2016. All forward-looking statements contained in this report 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.
About HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM)
HTG Molecular Diagnostics, Inc. is a commercial-stage company that develops and markets a technology platform to facilitate the routine use of complex molecular profiling. The Company’s HTG Edge and HTG EdgeSeq platforms, consisting of instrumentation, consumables and software analytics, are used in sample profiling applications, including tumor profiling, molecular diagnostic testing and biomarker development. The Company’s HTG Edge and HTG EdgeSeq platforms automate the molecular profiling of genes and gene activity using its nuclease protection chemistry on a range of biological samples. The Company’s HTG EdgeSeq chemistry, together with its HTG Edge or HTG EdgeSeq instrumentation and software, automates and adapts its nuclease protection chemistry to enable analysis using next generation sequencing (NGS) instrumentation. The HTG EdgeSeq system utilizes substantially the same sample preparation reagents as its original chemistry, but allows for read out on an NGS instrument. HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) Recent Trading Information
HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) closed its last trading session down -0.03 at 5.81 with 673,092 shares trading hands.