HTG Expands Features of Proprietary HTG EdgeSeq Technology

Rhea-AI Summary

HTG Molecular Diagnostics has announced a significant upgrade to its sample preparation process for the miRNA Whole Transcriptome Assay (miRNA WTA), allowing harmonization with the HTG Transcriptome Panel (HTP). This innovation enables the analysis of nearly 20,000 gene mRNA and over 2,000 miRNA from a single sample lysate, improving workflow efficiency. The new protocol is validated for various sample types including FFPE tissue. The company believes this advancement will enhance multiomic expression analysis and provide a competitive edge in tissue-preserving gene expression profiling.

Positive

• Improved sample preparation protocol for miRNA WTA harmonized with HTP.
• Enables analysis of mRNA and miRNA from a single sample lysate, enhancing workflow efficiency.
• Validated for multiple sample types, including FFPE tissue, facilitating broader usage.
• Expected to enhance the value proposition of HTG's EdgeSeq technology.

Negative

• Forward-looking statements indicate uncertainty about the expected benefits of the new protocol.
• Risks associated with customer adoption of the new workflows remain.

New Sample Preparation Harmonization Designed to Enable miRNA and mRNA Profiling Without the Need for Additional Sample

TUCSON, Ariz., April 06, 2022 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, announced that it has improved the sample preparation protocol for its miRNA Whole Transcriptome Assay (miRNA WTA) so that it is now harmonized with the HTG Transcriptome Panel (HTP).

The harmonized protocol is designed to enable customers to process a single sample with HTG’s nearly 20,000 gene mRNA and 2,000+ miRNA transcriptome panels using a single sample lysate. Validated for use with several commonly used sample types, including formalin fixed paraffin embedded (FFPE) tissue, PAXgene, and RNA extracted from FFPE or freshly frozen tissue, this approach is intended to allow customers to save time with better sample and workflow efficiency while generating more comprehensive expression data.

“Harmonization of our mRNA and miRNA workflows should facilitate the generation of more robust multiomic mRNA and miRNA expression analysis while furthering the value proposition of our HTG EdgeSeq technology as a tissue-preserving gene expression profiling (GEP) technology,” said Dr. Marian Navratil, HTG’s Senior Vice President of Research and Development. “Prior to completion of this harmonization, separate tissue sections and sample preparation processes were needed to analyze the full transcriptome. With this innovation, only a single tissue section and just one lysis method are typically expected to be required to release all the RNA needed for downstream testing without any confounding factors that could interfere with expression data.”

“We believe HTG now offers the only solution enabling extraction-free full transcriptomic profiling, both mRNA and miRNA, from a single tissue section,” said Byron Lawson, HTG’s Senior Vice President and Chief Commercial Officer. “Alternate GEP technologies typically require a minimum of 4-8 tissue sections, and often 12 or more sections for RNA extraction, as well as separate library preparation methods for RNA size selection for mRNA and miRNA processing. Our technology offers customers a streamlined workflow, with more efficient turnaround times and simplified bioinformatics. We are very optimistic that these advantages will encourage customers to interrogate mRNA using our HTP and miRNA using our miRNA WTA, while allowing them to retain precious samples for use in other analysis.”

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 harmonized sample preparation protocol for the miRNA WTA and the HTP, its expected benefits, advantages and features. 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, the risk that the harmonized protocol may not provide the expected benefits or advantages; risks associated with our ability to develop and commercialize our products; the risk that our products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all; 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; risks associated with the impact of the COVID-19 pandemic on us and our customers; 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-K for the year ended December 31, 2021, as filed with the SEC on March 29, 2022. 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 is the new sample preparation protocol announced by HTGM on April 6, 2022?

HTGM announced an improved sample preparation protocol for its miRNA Whole Transcriptome Assay (miRNA WTA) that harmonizes with the HTG Transcriptome Panel (HTP), allowing analysis from a single sample.

How does the new protocol impact the efficiency of sample processing for HTGM?

The new harmonized protocol improves workflow efficiency by enabling the analysis of mRNA and miRNA from a single sample lysate, reducing the need for multiple tissue sections.

What types of samples can be used with HTGM's new sample preparation protocol?

The protocol is validated for several types of samples, including formalin fixed paraffin embedded (FFPE) tissue, PAXgene, and RNA extracted from both FFPE and freshly frozen tissues.

What potential advantages does HTGM claim with their new sample preparation technology?

HTGM believes the new protocol will facilitate more robust multiomic analysis and streamline workflows, potentially attracting customers to their technologies.

What are the risks associated with the new protocol from HTGM?

The forward-looking statements in the press release highlight uncertainties regarding the adoption of the new protocol and whether it will deliver the expected benefits.