HTG Introduces HTG EdgeSeq Reveal RUO Oncology Applications

TUCSON, Ariz., Aug. 04, 2020 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. HTGM (HTG), a life science company whose mission is to advance precision medicine, today announced the pre-launch introduction of its new HTG EdgeSeq Reveal RUO oncology applications, which are expected to be commercially available globally in late August with the release of HTG EdgeSeq Reveal version 3.0.

In January 2019, HTG launched HTG EdgeSeq Reveal, a web-based biostatistical analysis software suite, which is designed to allow customers to streamline their analysis of samples processed with HTG's RUO profiling assays and accelerate their critical research. With the release of version 3.0, HTG introduces the first RUO oncology applications specifically built upon the HTG EdgeSeq Precision Immuno-Oncology Panel (PIP), including three complimentary signatures aimed at understanding the immune response (inflammation) and biology of the tumor microenvironment. These initial RUO oncology applications include:

• HTG EdgeSeq Reveal Immune Signature
• HTG EdgeSeq Reveal Stroma Signature
• HTG EdgeSeq Reveal Tumor Microenvironment Signature

"Our purpose-built signatures are intended to leverage the gene expression data from our PIP assay and enable researchers to better understand the tumor microenvironment including tumor inflammation (Hot vs. Cold) and stromal response to a tumor," said Marian Navratil, Vice President, Research and Development. "The approach for these signatures is based upon the xCell algorithm, one of the most well-documented gene signature-based methods that combines sophisticated gene enrichment and deconvolution approaches. These signatures were designed to be tissue-agnostic, having been developed from over 1,000 formalin-fixed, paraffin-embedded (FFPE) tissue samples across multiple different tumor types and orthogonally compared to multiple commonly used inflammation immunohistochemistry markers in an independent cohort."

Byron Lawson, Senior Vice President and Chief Commercial Offer, added, "Characterization of the immune response in the tumor microenvironment continues to be an important step in developing biomarker strategies to understand the body's immune response in relation to cancer biology and potential response to mono and combination therapies. Expanding the applications available through our HTG EdgeSeq Reveal software suite, we believe customers will have the ability to potentially accelerate their discovery, support translational applications, and determine potential biomarkers for development of companion diagnostics. These applications are the first of many we plan to commercialize in both Oncology and Immunology."

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. Its mission is to empower precision medicine.

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 capabilities and benefits of HTG EdgeSeq Reveal 3.0, including its RUO oncology applications, as well as our plans for the commercialization of additional applications in Oncology and Immunology. 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 but not limited to, the risk that HTG EdgeSeq Reveal 3.0, our HTG EdgeSeq RUO assays and related RUO applications may not provide the expected benefits or capabilities; the risk the we may not be successful in our efforts to commercialize additional applications; 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; and our ability to manufacture our products to meet demand. 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, 2020. 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:
Ashley R. Robinson
LifeSci Advisors, LLC
Phone: (617) 430-7577
Email: arr@lifesciadvisors.com