CHANDLER, Ariz.--(BUSINESS WIRE)--In recognition of its contribution to new innovations and tools in the field of molecular diagnostics for the advancement of precision medicine, HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) has been named a 2015 AZBio Fast Lane Company by the Arizona Bioindustry Association (AZBio).
“What is the patient’s genetic make-up and what is unique nature of their disease? How can we identify the best treatment path for this patient? These are questions that HTG Molecular Diagnostics’ molecular profiling tools help physicians answer,” shared Joan Koerber-Walker, president & CEO of AZBio. “With the right mix of engineering, chemistry, dedicated talent, and strategic partnerships, HTG Molecular diagnostics is changing the way we analyze and ultimately treat life threatening diseases.”
Precision medicine is the use of an individual’s molecular profile to guide treatment. The precision comes from advances in genetics and protein biochemistry that allow diseases to be identified and then broken down into subsets based on precise defects that cause the disease.
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 (NGS).
In June of 2014, HTG Molecular Diagnostics entered the next-generation sequencing space with the launch of its first assay, which targets and sequences 2,275 microRNAs using its proprietary nuclease protection probe technology. The company was also issued a U.S. patent for its novel HTG EdgeSeq chemistry that leverages the increasing installed base of NGS instruments for its profiling panels and substantially simplifies current sample and library preparation methods, and greatly reduces the complexity of data analytics. By combining the power of the HTG EdgeSeq chemistry with the capabilities of NGS, HTG Molecular Diagnostics is able to profile a wide variety of genomic alterations and sample types. These include RNA gene fusions and rearrangements, DNA mutations and analysis of cell-free circulating DNA from liquid biopsies.
In 2015, the company has achieved the following milestones:
- Completed initial public offering, receiving net proceeds of $44.2 million
- Completed research agreement with MD Anderson Cancer Center for Targeted Sequencing-based expression panels for lung cancer classification, fusion status and immune profiling
- Collaborated with advisory groups on suggested changes to the Genomic Sequencing Procedure codes which were accepted by the CPT Editorial Panel, and HTG Lung Fusion & Insertion panel received Z-Code from the McKesson Diagnostics Exchange
- Launched Oncology Biomarker Panel, the second profiling panel on the HTG EdgeSeq platform
- Joined the Worldwide Innovative Networking (WIN) Consortium in personalized cancer medicine as an official technology partner in July, 2015
- Completed recertification for ISO 13485:2003 valid through 2018
"After completing our successful initial public offering, we are excited to be working to accelerate our business strategies," said TJ Johnson, President and Chief Executive Officer. "We continue to make progress in our growth initiatives in panel expansion, market development in reimbursement and key research collaborations, and preparation for our first FDA submission. We believe we are well positioned to participate in the democratization of clinical molecular profiling."
Calimmune, Inc., HTG Molecular Diagnostics, Inc., and VisionGate, Inc. will be honored as AZBio Fast Lane Companies during the Tenth Annual AZBio Awards at the Phoenix Convention Center on October 1, 2015 in front of an audience of local, national, and international leaders.
The AZBio Fast Lane Award recognizes companies that surpassed crucial milestones on the journey from discovery to development to delivery. Significant progress can be measured by activity in the past 18 months in the areas of clinical results, regulatory approvals, certifications, collaborations, funding awards, product launches, job growth or product sales milestones.
Recent recipients of the AZBio Fast Lane Award include: SenesTech, Cancer Prevention Pharmaceuticals, and Pinnacle Transplant Technologies. For a full list of past honorees, visit www.azbio.org/azbio-awards-2015/awards-history.
For registration and more information, go to www.azbioawards.com.
AZBio – The Arizona Bioindustry Association – is comprised of member organizations in business, research, government, and other professions involved in the biosciences. AZBio supports the members of the Arizona bioscience community by providing access to the key resources, connections, and information that support their ability to Connect, Collaborate, Innovate and Succeed thus supporting the growth of a thriving economic ecosystem for Arizona’s Bioscience Industry. The AZBio Awards are an exciting opportunity to connect with Arizona’s fastest growing industry sector.
Images available upon request.