HTG Molecular Diagnostics Receives ISO 13485 Certification for Health Canada CMDCAS Requirements

• Supports continued growth of HTG’s clinical diagnostic business
  

TUCSON, Ariz., Sept. 18, 2017 -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents, and services for molecular profiling applications, today announced that is has successfully completed an audit of its Quality Management System for continued certification to ISO 13485. This certification was issued by a registrar accredited under the Canadian Medical Device Conformity Assessment System (CMDCAS), which is required by Health Canada for the company to market in vitro diagnostic (IVD) products in Canada.

"We are very proud of our teams for this accomplishment. HTG was first certified to ISO 13485 in 2012 and was re‑certified in 2015; this continued certification by a CMDCAS-recognized registrar highlights this long history and, we believe, clearly demonstrates our commitment to quality," said Sam Rua, Vice President of Regulatory Affairs and Quality Systems at HTG Molecular Diagnostics.

ISO 13485 is an internationally recognized quality standard certification that is required of medical device manufacturers by various authorities worldwide to demonstrate each manufacturer has a quality management system in place to consistently meet customer and regulatory requirements for the design, development, and commercialization of medical devices.

About HTG:
Headquartered in Tucson, Arizona, the mission of HTG Molecular Diagnostics (HTG) is to empower precision medicine at the local level. The company’s HTG EdgeSeq technology, which automates highly multiplexed molecular profiling of minute samples for next-generation sequencing, received its first US patent in 2014. Continuous improvements led to the 2017 launch of HTG’s new direct-target sequencing chemistry for DNA analysis offered in the company’s VERI/O services laboratory. 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 about the benefits of our Quality Management System and our ISO 13485 continued certification. 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, our ability to successfully develop, market and/or commercialize our products, including our ability to satisfy our customers’ product-quality requirements, or to obtain or maintain regulatory approvals for our products in Canada or any other jurisdiction. 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 June 30, 2017. 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 Robinson
LifeSci Advisors, LLC
617-775-5956
[email protected]

TJ Johnson
President/CEO
HTG Molecular Diagnostics
520-547-2827 x130
[email protected]