Tucson's HTG Molecular Speeds Gene Testing with Automated Unit ; New Tech Will Helpdoctors, Eventuallybenefiting Patients

By Wichner, David | AZ Daily Star, September 29, 2013 | Go to article overview

Tucson's HTG Molecular Speeds Gene Testing with Automated Unit ; New Tech Will Helpdoctors, Eventuallybenefiting Patients


Wichner, David, AZ 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. …

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