We are a commercial stage company that developed and markets a novel technologyplatform to facilitate the routine use of complex molecular profiling. Our HTG Edge automated platform can quickly, robustly and simultaneously profile thousands of clinically relevant molecular targets from samples a fraction of the size required by current technologies. Our objective is to establish the HTGEdge platform as a standard in molecular profiling and make this capability accessible to all molecular labs from research to the clinic. We believe that our target customers desire high quality molecular profiling information in a multiplexed panel format from increasingly smaller samples, with the ability to do this locally to minimize turnaround time and cost. The HTG Edge platform was designed to meet these needs and is empowering pathologists, clinicians and molecular labs to directly control the molecular profiling of patient samples.
Our HTG Edge platform is comprised of instrumentation, consumables and software analytics. Ou platform provides significant workflow and performance advantagesin molecular profiling applications, including tumor profiling, molecular diagnostic testing and biomarker development. Significant discoveries of new molecular targets, such as in the field of immuno-oncology, are creating substantial growth in targeted tumor profiling for molecular diagnostic testing, biomarker development and translational research in oncology and other diseases.
Based on published industry reports, the cancer profiling market is estimated to be $17.8 billion today and is expected to grow to $35.0 billion by 2018.
The HTG Edge platform automates the molecular profiling of genes and gene activity using our proprietary chemistry to deliver extraction-free, multiplexed results on a wide variety of biological samples, including tissue preserved with formaldehyde and stored in paraffin wax, which is referred to as formalin fixed paraffin embedded, or FFPE, tissue. We recently launched HTG EdgeSeq, an extension of our platform that automates and adapts our nuclease protection chemistry to enable analysis using next generation sequencing, or NGS,instrumentation.
The following features of our platform are designed to enable the rapid delivery of a comprehensive molecular profile from extremely small samples: .
- Multiplexing – analyze thousands of molecular targets in a single sample, providing a more comprehensive profile .
- Minimal sample requirement – molecular profile from extremely small amounts of sample, such as a fine needle aspirate .
- Multi-parameter testing – measure multiple molecular applications such as RNA expression, RNA fusions and rearrangements, DNA mutations and protein expression
- Data quality – high fidelity results from a broad range of biological samples including difficult to use FFPE tissue
- Speed – turnaround time of 24-36 hours
- Ease of use – minimal labor, simple user interfaces and turnkey analytics Our innovative platform and initial menu of molecular profiling panels are being utilized by a wide range of customers including biopharmaceutical companies, academic institutions and molecular labs to simultaneously analyze a comprehensive set of molecular information from valuable clinical samples and substantially improve their workflow efficiency.
Our platform’s proprietary chemistry allows for extraction free analysis of difficult clinical samples such as FFPE tissue with as little as a single five micron section of tissue, a fraction of the amount of sample required by existing technologies. The ability to provide robust data from minute samples is critically important in areas such as cancer where biopsies are becoming less invasive and smaller while the number of tests competing for the sample is growing. Our platform was designed to fit seamlessly into current surgical pathology workflows, minimize technician labor and set a new standard for ease of use. We currently market seven proprietary molecular profiling panels that address the needs of almost 40 customers in high impact areas of translational research and biopharmaceutical companion diagnostics, including immuno-oncology, the expression of important genes such as fibroblast growth factor receptor, or FGFR, and human microRNA analysis.
In June 2014, we were issued a U.S. patent for our novel HTG EdgeSeq chemistry that allows us to leverage the increasing installed base of NGS instruments for our profiling panels. This new HTG EdgeSeq chemistry utilizes the same sample preparation instrument and reagents as our original chemistry, but allows for read out on an NGS instrument. We believe the HTG EdgeSeq chemistry is disruptive as it substantially simplifies current sample and library preparation methods, greatly reduces the complexity of data analytics, and provides customers additional value by expanding the utilization of their NGS investments. By combining the power of the HTG EdgeSeq chemistry with the capabilities of NGS, we are able to profile a wide variety of genomic alterations and sample types. These include RNA gene fusions and rearrangements, DNA mutations and analysis of cell-free circulating DNA from liquid biopsies. These capabilities provide us substantial ability to develop additional profiling panels and grow our market opportunities. We have a focused development pipeline of new profiling products that includes panels for translational research, drug development and molecular diagnostics. Our product strategy is to build complete profiling panels of established and emerging molecular targets for broader and disease-specific approaches. For our molecular diagnostic customers where the reimbursement path is critical, we expect that our planned panels will conform to approved reimbursement codes for genomic sequence procedures. We believe this will facilitate clinical customer adoption and avoid the high costs and time required to prove medical utility and seek unique reimbursement codes.
The company was originally incorporated in Arizona in October 1997 as “High Throughput Genomics, Inc.” In December 2000, it was reincorporated in Delaware as “HTG, Inc.” and in March 2011 changed our name to “HTG Molecular Diagnostics, Inc.”
The company’s principal executive offices are located at 3430 E. Global Loop, Tucson, AZ 85706, and our telephone number is (877) 289-2615. The corporate website address is www.htgmolecular.com.