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HTG Announces an Early Access Program for its Prototype Whole Transcriptome Panel

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HTG Molecular Diagnostics (Nasdaq: HTGM) has launched an Early Access Program for its new whole transcriptome panel, utilizing HTG EdgeSeq technology. This program allows select customers to test the panel before its commercial release, anticipated in mid-2021. The technology can analyze approximately 20,000 mRNA targets without the need for RNA isolation, which benefits small or low-quality samples. The initiative aims to collect user insights from key opinion leaders in academia and pharmaceuticals to refine the product.

Positive
  • Launch of Early Access Program for whole transcriptome panel.
  • Expected commercial launch in mid-2021.
  • Technology allows analysis of 20,000 mRNA targets without RNA isolation.
Negative
  • Risks associated with commercializing the whole transcriptome panel.
  • Uncertainty regarding adoption by academic and pharmaceutical collaborators.
  • Competition within the industry may impact product success.

TUCSON, Ariz., Dec. 08, 2020 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced that it has launched an Early Access Program for its whole transcriptome panel using the HTG EdgeSeq technology. The Early Access Program is intended to allow select customers access to the panel in their laboratories or through services to be performed in our development laboratory prior to commercial launch of this product.

HTG announced the completion of proof of concept for a prototype whole transcriptome panel and demonstrated technical feasibility in November 2020. The panel is expected to allow for analysis of the entire known human transcriptome (approximately 20,000 mRNA targets) while retaining the advantages of HTG’s smaller targeted panels, including the ability to run small sample sizes without requiring RNA isolation and purification and the ability to successfully process low-quality samples.

“The Early Access Program is intended to allow HTG to collaborate with key opinion leaders in academia and pharmaceutical companies to evaluate our prototype whole transcriptome panel and associated simplified workflow in a real-world setting, providing a more thorough assessment of different user experiences,” said Byron Lawson, Chief Commercial Officer. “Comparison of collaborator experiences across many of the most prevalent oncology and immune indications is expected to provide us with valuable insight into the capabilities of this panel and help guide our next development steps as we progress towards commercial launch in mid-2021.”

About HTG:
HTG is focused on NGS-based molecular profiling. The company’s proprietary HTG EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG’s customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries, and ultimately to identify treatment options. Our mission is to empower precision medicine at the local level.

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 Early Access Program allowing select customers access to our whole transcriptome panel in their laboratories or through services to be performed in our laboratory prior to commercial launch of the panel; the panel being expected to allow for analysis of the entire known human transcriptome while retaining the advantages of HTG’s smaller targeted panels; the Early Access Program being intended to allow HTG to collaborate with key opinion leaders in academia and pharmaceutical companies to evaluate our prototype whole transcriptome panel and associated simplified workflow in a real-world setting, providing a more thorough assessment of different user experiences; the expectation that a comparison of collaborator experiences across many of the most prevalent oncology and immune indications will provide us with valuable insight into the capabilities of our whole transcriptome panel and help guide our next development steps; and the expected timing of our commercial launch of our whole transcriptome panel. Words such as “expects,” “intends,” “progress towards” 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 our HTG EdgeSeq whole transcriptome panel may not provide the benefits we expect; risks associated with our ability to successfully launch and commercialize our whole transcriptome product and our other products and services; the risk that our products and services may not be adopted by collaborators in academia or pharmaceutical companies as anticipated, or at all; our ability to manufacture our products to meet demand; the level and availability of third party payor reimbursement for our products; our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; 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, including without limitation our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. 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 R. Robinson
Phone: (617) 430-7577
Email: arr@lifesciadvisors.com


FAQ

What is the purpose of HTG's Early Access Program launched in December 2020?

HTG's Early Access Program allows select customers to evaluate their new whole transcriptome panel before its commercial launch, enabling real-world testing and feedback.

When is the expected commercial launch date for HTG's whole transcriptome panel?

HTG anticipates the commercial launch of its whole transcriptome panel in mid-2021.

What advantages does HTG's whole transcriptome panel offer?

The panel can analyze around 20,000 mRNA targets while processing small or low-quality samples without requiring RNA isolation.

What potential risks are associated with HTG's new whole transcriptome panel?

Potential risks include challenges in commercialization, uncertain adoption rates, and competition in the molecular profiling industry.

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