HTGM HTG Molecular Diagnostics Inc

HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents, and services for molecular profiling applications, today announced that its HTG EdgeSeq technology will be used together with Illumina next-generation sequencing (NGS) in a clinical trial conducted by the Worldwide Innovative Networking Consortium (WIN) investigating a novel therapeutic approach using a combination of three targeted therapies for the first line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Earlier today, WIN announced the US Food and Drug Administration (FDA)’s approval to begin the Survival Prolongation by Rationale Innovative Genomics (SPRING) trial, which will aim to enroll NSCLC patients who are usually offered first line platinum-based chemotherapy, and who lack documented targetable driver alterations (EGFR mutations, ALK rearrangements, ROS1 and MET exon 14 skipping mutations). The population of NSCLC patients envisioned for the enrollment in SPRING trial represents the vast majority of patients with metastatic NSCLC (~80% in the Caucasian population). WIN also announced that the SPRING trial will test, as a first-line combination treatment, three drugs from WIN’s pharma members: Merck KGaA’s Avelumab combined with Pfizer’s Palbociclib and Axitinib. The SPRING trial is planned to be launched in 5 countries and 8 WIN member sites.

The SPRING trial further aims to validate a novel algorithm SIMS (Simplified Interventional Mapping System) developed by WIN and designed to match each patient’s tumor biology to a specific drug combination. For this purpose, both tumor and normal lung tissue biopsies obtained in the SPRING trial will be tested using HTG EdgeSeq mRNA and miRNA expression panels.

“We are proud to be involved with WIN as a key gene expression technology partner in the SPRING trial, which tests a novel therapeutic approach to better diagnose and treat patients afflicted with lung cancer,” stated TJ Johnson, HTG President and CEO. “We believe HTG EdgeSeq technology will enable WIN members to measure quantitative expression of both mRNA and miRNA from the very small, challenging sample types likely to be encountered in the SPRING trial.”

“Interaction with HTG experts to deploy and validate transcriptome technologies needed for the SPRING patient’s tumor molecular profile characterization was exemplary,” said Dr. Vladimir Lazar, WIN Chief Scientific and operating officer. “We found the HTG EdgeSeq technologies robust and to meet our precision oncology needs,” added Dr. Lazar.

HTG joined WIN as an official technology partner in 2015.

About HTG:

Headquartered in Tucson, Arizona, the mission of HTG Molecular Diagnostics (HTG) is to empower precision medicine at the local level. In 2013 the company commercialized its first instrument platform and a portfolio of RNA assays that leveraged HTG's original proprietary nuclease protection chemistry. Continuous improvement led to the 2014 launch of the company’s 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 about the benefits of using HTG technologies in the WIN SPRING trial. 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 WIN clinical trials occur when expected, or at all, the risk that HTG EdgeSeq technology may not provide the anticipated benefits to WIN members or WIN clinical trials, and the capabilities of HTG products to keep pace with rapidly changing technology and user requirements. 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, 2017. 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:  Westwicke Partners
Jamar Ismail
Phone: (415) 513-1282
Email: jamar.ismail@westwicke.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: (520) 547-2827 x130
Email: tjjohnson@htgmolecular.com