TUCSON, Ariz. — 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.