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Tucson’s HTG Molecular Speeds Up Genetic Testing

By David Wichner Arizona Daily Star

Nearly 30 years ago, a University of Arizona pathologist had an idea for an automated tissue- slide-staining device that would help patients by enabling rapid analysis of biopsy samples.

The product envisioned by Dr. Thomas Grogan evolved into a company, Ventana Medical Systems, that was later acquired by Swiss drug giant Roche for $3.4 billion and is still growing today in Oro Valley.

Today, another homegrown company is looking to follow a similar path by automating its process for gene-based testing.

HTG Molecular Diagnostics has taken its proprietary, high-capacity platform for testing gene expression and incorporated it into an automated instrument that shrank a three-day process into a 24-hour turnaround.

And, with the help of a new federal grant worth up to $1.6 million, Tucson-based HTG is looking to adapt its instrument to next-generation genetic sequencers.

“Think of it as what Dr. Grogan did — we’ve basically now automated chemistry for analyzing genes,” said T.J. Johnson, CEO of HTG and a former Ventana Medical executive.

HTG’s Edge instrument, launched last fall, is based on the company’s core technology, which allows researchers to rapidly test multiple samples for the presence of an array of genetic markers at once.

The technology, known as quantitative nuclease protection assay, or qNPA, focuses on RNA (ribonucleic acid), which takes its cue from DNA (deoxyribonucleic acid) to act as a messenger at the cellular level to prompt the creation of proteins that alter cell function.

While HTG had been providing qNPA test kits to some users, it has primarily run tests for customers as a service business, Johnson said.

But that service business model was a barrier to wider adoption, he said.

“For us to have broad adoption, we needed to have a platform that we could take out to the market that dramatically simplified the process of the chemistry and the technology,” Johnson said. “We feel that having the combination of a service and a product offering gives us the broadest reach in the market.”

In a two-year development effort, HTG took a multistep, labor-intensive test process that used several instruments and miniaturized it into a tabletop processor and a smaller reader.

The system provides “walk-away automation” — simply load samples and chemicals called reagents, push the “on” button and come back a day later for results, Johnson said.

The design won a Silver award in this year’s Medical Design Excellence Awards, the medical technology industry’s major design awards competition.

HTG’s technology uses 96-well sample plates, with each tiny well imprinted with 47 different gene targets. A chemical probe is inserted in each well and results are read via an imaging system that translates the findings to data. The company is pushing this “multiplexing” to new heights, successfully testing upward of 2,500 genes in a single test, Johnson said.

That high throughput capacity will help physicians capitalize on the vast amounts of information generated by researchers worldwide since the human genome, or complete genetic code, was first mapped in 2003.

Genetic markers already are being used to test for specific diseases, such as some cancers, and HTG’s new instrument will give researchers and clinicians a way to rapidly test for a wide array of those markers, Johnson said.

“We’re bringing a new capability, bringing diagnostic and translational applications to the clinic, which means it’s getting closer to the patient,” he said. “In the last 10 years, all of these phenomenal discoveries have been made, but if you look at how many have worked their way into actual clinical care, it’s very few. So we’re really trying to develop a product that’s going to improve that pipeline.”

The Edge requires very small samples and, unlike other methods, requires no extraction or amplification of RNA, Johnson said. The technology is used mainly with tissue, including paraffin-fixed samples, but can also be used with blood, saliva or other bodily fluids.

“Probably one of the biggest issues facing testing labs and physicians today is that we now have so many new things that we’ve discovered, and so many new types of tests to run, but we have smaller and smaller amounts of tissue or sample to work with,” he said.

“We’re able to start with less material, which is a positive, and then we’re able to give more answers, more information on more genes, with those smaller pieces of sample.”

Amanda Baker, an associate UA professor of medicine and member of the Arizona Cancer Center, said there are other RNA-based technologies for gene expression, but HTG’s offers faster results using a wide variety of sample types.

“I was very attracted to the HTG platform because you can use paraffin-embedded tissue very easily. Rather than having to have fresh tissue, you can use fixed (tissue) which is what is usually clinically available,” said Baker, whose recent research has focused on DNA pathways that are important targets in cancer, including lymphoma, ovarian cancer and breast cancer.

Whether it’s for drug research or clinical diagnostics, the speed of the Edge system will save crucial time in the lab, said Baker, who has had a lab at the Cancer Center since 2005.

“In a lab setting, to me it’s great to get the data back the next day with very little tech time,” she said.

The company has placed a few Edge units with some “early adopters” for drug research, Johnson said. The identity of those customers is being kept confidential for now, but they include a major drug company, a research institution and a diagnostic lab.

A new federal grant will give HTG the opportunity to take its Edge system to a whole new level.

In early September, the National Human Genome Research Institute of the National Institutes of Health awarded HTG a Phase II SBIR (Small Business and Innovative Research) grant of $1.01 million for the company to continue efforts to adapt its Edge system to next-generation genetic sequencers, with an opportunity for a follow-on grant of $587,000 next year.

The recent EdgeSeq award follows a two-year, $599,000 Phase I SBIR grant project, in which the Edge was tested with genetic sequencers made by Life Technologies and Illumina. The idea, Johnson said, is to make the Edge system adaptable to off-the-shelf RNA and DNA sequencers.

Though HTG’s core technology is based on RNA, the Edge system has been shown to work with DNA as well, Johnson said.

“We’ve basically opened up the chemistry to be able to work with RNA and DNA. So our first product will actually be an RNA-based product, but we’ll be following fairly quickly with DNA-based products,” he said.

The move to sequencing and DNA is critical for HTG, Johnson said.

“It dramatically opens up the world of translational medicine and diagnostics to us, and instead of viewing sequencing as a potential threat to the company, it’s now a synergy — we can ride the wave of next-generation sequencing technology, versus being pummeled under the wave,” he said.

Even so, Johnson said the diagnostics market — expected to top $10 billion globally in the next five years — is highly competitive.

But HTG has some strong investor backing, including the investment arms of drug giants Merck and GlaxoSmithKline, as well as key research collaborations.

Johnson said the company, which has more than doubled its staff in the last two years to about 50 employees, will likely need a new round of funding to finalize development of the Edge system and reach a goal of positive revenue by 2015.

In the coming weeks and months, HTG will be publishing its results in peer-reviewed journals and seeking new collaborations, Johnson said.

“We’ve taken our value proposition and almost put it on steroids, and we’re really excited about it,” he said, “and I think the market is going to respond to it extremely well.”

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Page last updated January 25, 2017