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HTG Expands RUO Profiling Menu with New Platform Compatibility Assays

1083 Days ago

HTG EdgeSeq DLBCL Cell of Origin Assay and the HTG EdgeSeq Lung Fusions RUO Assay now available for use on Thermo Fisher Scientific Ion Torrent NGS platform

TUCSON, Ariz., July 15, 2019 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a diagnostic company whose mission is to advance precision medicine, today announced the introduction of two of its previously released assays, the HTG EdgeSeqTM DLBCL Cell of Origin Assay and the HTG EdgeSeq Lung Fusions RUO Assay, for use with the Thermo Fisher Scientific Ion Torrent TM Ion S5 (Ion S5) next-generation sequencing (NGS) platform.

The HTG EdgeSeq DLBCL Cell of Origin Assay is designed to determine the molecular sub-type of Diffuse Large B-Cell Lymphomas (DLBCL) using a gene expression-based classification system. Sub-typing DLBCL into Activated B-Cell-like (ABC) and/or Germinal Center B-Cell-like (GCB) has shown potential clinical importance in determining tumor behavior.

The HTG EdgeSeq Lung Fusions RUO Assay is designed to measure and analyze mRNA ALK gene fusion events in formalin-fixed, paraffin-embedded (FFPE) lung tumor specimens from patients previously diagnosed with non-small cell lung cancer.

 “With initial increasing demand in our European market for our profiling assays, we are pleased to add these new Ion S5 platform-compatible assay offerings to our RUO Profiling Assay menu,” stated Jean Claude Gerard, Senior Vice Present, European Operations of HTG.

“Our sequencer-agnostic approach allows those customers who have made the investment in an NGS system to adopt our assays without having to invest in a new sequencing system,” added John Lubniewski, President and CEO of HTG. “We are thrilled to be the assay of choice for many of our customers and are committed to continuing to expand our menu to meet their needs.”

About HTG
HTG is focused on 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 the expected benefits that the HTG EdgeSeq DLBCL Cell of Origin Assay and the HTG EdgeSeq Lung Fusions RUO Assay for use with the Ion S5 platform will provide to our customers . 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 our HTG EdgeSeq assays may not provide the expected benefits; 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 third 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 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 March 31, 2019. 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
Email: arr@lifesciadvisors.com

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