TUCSON, Ariz., July 23, 2015 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, today announced that its has again achieved ISO 13485:2003 certification for the design, manufacture, and distribution of instruments, software, reagents and test kits used in the analysis of gene expression. The re-certification covers the design, development, production, and sale of the patented qNPA technology-based products and services in HTG Molecular Diagnostics' portfolio.
To earn this internationally recognized quality standard certification, an organization is required to demonstrate it has quality management systems in place to consistently meet customer and regulatory requirements for the design and development of medical devices.
"HTG obtained the initial certification to ISO 13485:2003 in 2012, and this most recent recertification demonstrates the company's continued commitment to quality in the development and provision of qNPA technology-based products and services, maintaining a solid foundation for the future growth of HTG's clinical diagnostics business," stated Sam Rua, Vice President of Regulatory Affairs and Quality Systems at HTG Molecular Diagnostics.
About HTG:
Headquartered in Tucson, Arizona, HTG Molecular Diagnostics' 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 Edge system capabilities have been expanded to fully automate sample and targeted library preparation for next-generation sequencing.
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 future growth of our business and the capabilities of our technology. 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 inherent in molecular profiling research and development activities. These and other factors are described in greater detail in our Quarterly Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 (Form 10-Q), filed with the Securities and Exchange Commission on June 8, 2015. 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.