HTG Moves to Next Phase of HTP Product Development

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TUCSON, Ariz., December 22, 2021 (GLOBE NEWSWIRE) – HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine with its innovative profiling technology in the At the transcriptome scale, the potential markets and applications of its pioneering HTG Transcriptome Panel (HTP) have now expanded. Since the launch of HTP with commercial availability in the US and Europe in August 2021, HTG has completed validation of additional sample types that are more commonly used outside of oncology, and has also expanded the capabilities of sequencing to facilitate testing of larger sample cohorts.

Initially validated for neoplastic tissues, HTG has now validated HTP for use with normal FFPE tissues and other non-neoplastic tissues. Additionally, the panel was validated with PAXgene, a popular liquid blood sample type, and with RNA extracted from fresh frozen tissue samples and FFPE.

Additionally, to maximize sequencer flexibility, HTP is now validated across Illumina’s entire production-scale sequencer portfolio, including the NextSeq 500/550, NextSeq 1000/2000 and NovaSeq 6000. This will allow HTG customers to more efficiently sequence larger sample cohorts, which HTG believes will significantly increase the efficiency of data generation, in addition to reducing the time to results and the overall cost of customer studies.

“We are extremely pleased with the initial interest in the HTG Transcriptome Panel among leaders in biopharmaceutical and academic research, as evidenced by our recent achievement in late November of the first million dollars in revenue recognized after the commercial launch,” said Byron Lawson, Senior Vice President and Chief Commercial Officer. “Our initial validation and launch of HTP focused primarily on FFPE neoplastic tissue samples in oncology. We expect that validation of additional sample types will open additional business opportunities in areas such as immunology, autoimmune diseases and disorders, and infectious diseases. Extending sequencer validation to meet Illumina’s full line of production-scale sequencers is critical to supporting studies of all sizes and maximizing study flexibility for our customers. We believe that the universal genetic content of HTP, together with the expansion of sample types and the flexibility of the sequencer, will further stimulate demand for this breakthrough product and allow us to continue our plans to expand the commercial market.

Measuring approximately 20,000 mRNA targets using HTG’s proprietary HTG EdgeSeqMT technology, HTP can be deployed to profile a wide range of diseases, help identify new drug candidates, develop molecular classification tools, and discover critical biomarkers. HTG’s panel reduces sample quantity requirements, is less sensitive to RNA degradation due to sample age, and offers faster turnaround times than other methods currently available . HTP has also been shown to have a higher sample success rate than RNA-Seq for gene expression profiling. HTG previously published a series of white papers highlighting these capabilities and performance metrics which can be found here. HTG plans to continue providing additional internal and expected third-party validation data for HTP in future periods.

About HTG:

HTG is accelerating precision medicine from diagnosis to treatment by harnessing the power of transcriptome-scale profiling to conduct translational research, clinical diagnostics and targeted therapies in a variety of disease areas.

Building on more than a decade of pioneering innovations and partnerships with biopharmaceutical leaders and leading academic institutes, HTG’s proprietary RNA platform technologies are designed to make the development of science tools and diagnostics more effective and efficient life and to unlock a differentiated and disruptive approach to drug discovery transformation. For more information, visit www.htgmolecular.com.

Safe Harbor Declaration:

Statements in this press release regarding matters which are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expansion of potential markets and applications for HTP, the capabilities and benefits of HTP, additional business opportunities for HTP, demand for HP, and additional internal and third-party validation for HTP. Words such as “designed for”, “believes”, “anticipates”, “plans”, “foresee”, “intends”, “will”, “objective”, “potential” and other similar expressions are intended identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on management’s current expectations, are subject to known and unknown risks, and involve assumptions which may never materialize or may prove to be inaccurate. Actual results and timing of events could differ materially from those anticipated in these forward-looking statements due to various risks and uncertainties, including, without limitation, risks associated with the impact of the COVID-19 pandemic on us and our customers; the risk that HTP will not provide the benefits we expect; risks associated with our ability to develop and market our products, including HTP; the risk that HTP or our other products and services may not be adopted by biopharmaceutical companies or other customers as intended; our ability to manufacture our products to meet demand; competition in our industry; additional capital and availability of credit; our ability to attract and retain qualified personnel; and product liability claims. These and other factors are described in more detail in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended. September 30, 2021, as filed with the SEC on November 10, 2021. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we do not undertake to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.

HTG investor contact:

Ashley robinson
LifeSci Advisors
Telephone: (617) 430-7577
Email: arr@lifesciadvisors.com


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