HTG Completes HTP Product Next-Phase Development Milestone

Rhea-AI Summary

HTG Molecular Diagnostics has expanded the HTG Transcriptome Panel (HTP) to include additional sample types beyond oncology, such as normal FFPE and PAXgene blood-based samples. This expansion enables broader applications in fields like immunology and infectious diseases. The HTP is now validated for Illumina's full range of sequencers, enhancing efficiency and reducing costs for large-scale studies. Following its August 2021 launch, HTG recognized $1 million in revenue from HTP. This innovation aims to improve precision medicine by profiling approximately 20,000 mRNA targets, aiding drug discovery and biomarker identification.

Positive

• Expanded HTG Transcriptome Panel (HTP) applications to non-neoplastic tissues and blood samples, increasing market potential.
• Achieved $1 million in revenue post-commercial launch of HTP, indicating strong market interest.
• Validation across Illumina's complete portfolio of sequencers enhances study efficiency and flexibility.

Negative

• None.

Expands Potential Market and Study Opportunities for HTG Transcriptome Panel

TUCSON, Ariz., Dec. 22, 2021 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, has now expanded the potential markets and applications for its pioneering HTG Transcriptome Panel (HTP). Since launching 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 also expanded sequencing capabilities to facilitate easier testing of larger sample cohorts.

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

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

“We have been extremely pleased with the initial interest in the HTG Transcriptome Panel among leaders in biopharma and academic research, evidenced by our recent achievement at the end of November of the first $1.0 million of revenue recognized post commercial launch,” said Byron Lawson, Senior Vice President and Chief Commercial Officer. “Our initial validation and launch of HTP was primarily focused on neoplastic FFPE tissue samples in oncology. We expect the validation of additional sample types to enable additional commercial opportunities in fields such as immunology, autoimmune diseases and disorders, and infectious disease. Expanding sequencer validation to address Illumina’s complete portfolio of production-scale sequencers is critical to supporting studies of all sizes and maximizing study flexibility for our customers. We believe the universal gene content of HTP, coupled with the expansion of sample types and sequencer flexibility, will further drive the demand for this revolutionary product and enable us to further execute our commercial market expansion plans.”

Measuring approximately 20,000 mRNA targets using HTG’s proprietary HTG EdgeSeq^TM technology, HTP can be deployed to profile a wide range of diseases, assist in identifying new drug candidates, develop molecular classification tools and discover critical biomarkers. HTG’s panel reduces sample amount requirements, is less sensitive to RNA degradation due to sample age, and provides faster turnaround times than other, currently available methods. HTP has also been shown to have a higher sample success rate than RNA-Seq for gene expression profiling. HTG previously released a series of White Papers highlighting these capabilities and performance measures which can be found here. HTG expects to continue to provide 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-wide profiling to drive translational research, clinical diagnostics and targeted therapeutics across a variety of disease areas.

Building on more than a decade of pioneering innovation and partnerships with biopharma leaders and major academic institutes, HTG’s proprietary RNA platform technologies are designed to make the development of life science tools and diagnostics more effective and efficient and to unlock a differentiated and disruptive approach to transformative drug discovery. For more information visit 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 regarding the expansion of the potential markets and applications for HTP, capabilities and benefits of HTP, additional commercial opportunities for HTP, demand for HP, and additional internal and third party validation for HTP. Words such as “designed to,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, although 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 associated with the impact of the COVID-19 pandemic on us and our customers; the risk that HTP may not provide the benefits that we expect; risks associated with our ability to develop and commercialize 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 anticipated; our ability to manufacture our products to meet demand; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission (SEC), including under the “Risk Factors” heading 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 undertake no obligation to update such 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                         
Phone: (617) 430-7577                
Email: arr@lifesciadvisors.com

FAQ

What new applications does HTG's Transcriptome Panel (HTP) support as of December 2021?

HTG's Transcriptome Panel now supports validation for normal FFPE tissue, PAXgene blood samples, and other non-neoplastic tissues, expanding its applications beyond oncology.

How much revenue did HTG recognize from the Transcriptome Panel after its commercial launch?

HTG recognized $1 million in revenue from the Transcriptome Panel following its commercial launch in August 2021.

What are the benefits of HTG's Transcriptome Panel for researchers?

HTG's Transcriptome Panel profiles approximately 20,000 mRNA targets, allowing faster results, reduced sample requirements, and improved accuracy in gene expression profiling.

What sequencers is the HTG Transcriptome Panel validated for?

The HTG Transcriptome Panel is validated across Illumina’s NextSeq 500/550, NextSeq 1000/2000, and NovaSeq 6000 sequencers.

What markets does HTG aim to enter with its expanded Transcriptome Panel?

HTG aims to enter markets in immunology, autoimmune diseases, and infectious diseases with the expanded capabilities of its Transcriptome Panel.