HTG Molecular Diagnostics Inc.

Company Overview

HTG Molecular Diagnostics Inc. is developing and commercializing automated systems for target capture and library preparation at the front end of NGS for analyzing miRNA, mRNA, fusions, and DNA.

HTG’s lead platform is HTG Edge, which can analyze more than 2,500 genes from extremely small clinical samples, either tissue samples (single micron sections) or liquid biopsy (12.5 microliters). The Edge platform uses proprietary nuclease protection chemistry and NGS methods.

The nuclease protection probe chemistry eliminates many of the upfront steps needed for library preparation, including DNA extraction, cDNA synthesis, selection, and shearing. This enables the system to only require very small sample sizes, while at the same time providing higher sensitivity, giving it an advantage in clinical applications. This workflow helps to differentiate HTG from other tumor-tissue diagnostics.

HTG markets a series of EdgeSeq RUO and EdgeSeq CE-IVD assays. CE-IVD assays include the ALK Plus and CLBCL Cell of Origin assays.

The DLBCL Cell of Origin assay addresses the market’s need for patient subtyping. Subtyping is important because several new drugs have been developed for one of several DLBCL COO subtypes, including ABC or GCB.

The DLBCL subtyping market consists of the following companies: NanoString’s Lymph2Cx (agreement with Celgene to develop test as companion diagnostic for Revlid), Cleveland Clinic (RT-PCR method using Qiagen’s Modaplex) and HTG Molecular.

In August 2020, HTG formed an alliance with Qiagen Manchester (a subsidiary of Qiagen); the agreement includes a 10-year commercialization and distribution component, with the goal to offer pharmaceutical companies’ global development, distribution and commercialization capabilities for companion diagnostic assays based on HTG’s EdgeSeq platform.

In 2020, HTG developed its whole transcriptome gene expression profiling platform, called WTTx. The company plans to develop oncology assays and tests for autoimmune disorders and infectious diseases. This includes an early access program and commercial launch of the platform in the second half of 2021.

Financial Highlights (FY 2022)

Company's Business Segments

• Product revenue : Gene expression profiling, HTG EdgeSeq Instruments, Consumables.
• Product-related services revenue : RUO sample processing using our HTG EdgeSeq Instruments, Consumables in VERI/Olaboratory, Custom RUO Assay Design.