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HTG Molecular Diagnostics and Firalis Announce Agreement to Develop a Theranostic Tool to Predict Response to Anti-TNF-alpha Therapies for Rheumatoid Arthritis

TUCSON, Ariz. and HUNINGUE, France, July 06, 2016 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM) (“HTG”), a provider of instruments and reagents for molecular profiling applications, and Firalis S.A. (“Firalis”), a provider of bioanalytical services and biomarker-based products to biopharma, to biotechnology companies, and to academia, today announced an agreement to develop a next‑generation sequencing (NGS)-based theranostic tool to identify likely non-responders from responders to anti‑TNFα therapy for rheumatoid arthritis (RA).

RA is a chronic inflammatory disease that affects millions of people in the United States and Western Europe. TNFα-inhibiting therapies, the blockbusters representing a multibillion dollar market, have shown a major breakthrough in the treatment of RA. However, these drugs are found to lack efficacy in an estimated 30 to 40 percent of patients (non-responders). The RABIOPRED* tool aims to identify the non-responders to improve patient management. Under the agreement, HTG will supply instrumentation and reagents to support Firalis’ development, validation, and clinical deployment of RABIOPRED, a biomarker assay to predict treatment response in RA, using the NGS-based HTG EdgeSeq system.

“Firalis was the first adopter of the HTG Edge and HTG EdgeSeq systems in Europe, and we are pleased to expand our relationship through this personalized medicine initiative,” said TJ Johnson, President and CEO of HTG. “We are also happy to have Firalis as a certified service provider.”

“Millions of RA patients are treated with TNFα-inhibiting agents but the clinicians currently are unable to predict patient response to these expensive biologicals,” said Hueseyin Firat, President & CEO of Firalis. “We believe the ability to predict response to anti‑TNFα treatment would greatly improve clinical decision-making, improve health outcomes for RA patients, and contribute to cost reduction and sustainability of the health care system.”

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 benefits of our agreement with Firalis S.A. (specifically its affiliate Tc Land Expression S.A.), the impact of TNFα-inhibiting therapies on rheumatoid arthritis treatment and the size of the market, the ability to predict treatment response in rheumatoid arthritis, and the potential to contribute to health care system improvements. 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 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 March 31, 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.

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

About FIRALIS

Firalis is a biotechnology company with a mission to improve disease outcome, therapeutic decisions and generate savings in healthcare through biomarker discovery, development and regulatory qualification that ultimately leads to biomarker-based diagnostics. Firalis develops and markets RUO (Research-use-only) and IVD (In-vitro-diagnostic) kits in the field of cardiovascular (heart failure), neurodegenerative (Alzheimer's disease), inflammatory and autoimmune diseases (rheumatoid arthritis). With a strong expertise, a cutting-edge laboratory equipment and a very high quality environment (ISO 9001, ISO 13845, ISO 17025 and NF S 96-900), Firalis provides a comprehensive range of biomarker services from research to clinical applications in key therapeutic areas.

*RABIOPRED is a Tcland Expression project, realized in the framework of Horizon 2020 SME Instrument (Grant # 666798) funded by European Commission.

To get further information on Firalis Biomarker Services and its capabilities to successfully level up customer’s projects, please contact sales@firalis.com.

Firalis S.A.
35 Rue du Fort
F-68330 Huningue
Phone +33 389 911 320-8
http://www.firalis.com/

Source:HTG Molecular Diagnostics, Inc.