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HTG Molecular to File Edge System with US, European, Canadian Agencies for Dx Use by Year End

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HTG Molecular is preparing a triad of submissions for its Edge System in the US, EU, and Canada, a company executive said this week.

Chris Roberts, vice president of marketing and medical innovation at the Tucson, Ariz.-based firm, told BioArray News that HTG aims to file the Edge with agencies in all three territories by the end of 2013.

He declined to discuss what assays the firm would file for clearance, saying that HTG prefers to keep its diagnostics pipeline "close to its vest," though he said that two tests were competing to be the company's first regulatory filing. HTG aims to eventually sell those assays, and more, as kits to CLIA labs within the US, and diagnostic labs in the EU and Canada, Roberts said.

HTG debuted the Edge System last year. The automated, benchtop instrument enables users to profile mRNA and microRNA expression changes in up to 47 genes per well of a 96-well plate. Based on HTG's quantitative nuclease protection technology, the Edge supports assays that do not require RNA extraction, amplification, or labeling, according to the firm. In addition, the Edge was developed to enable the analysis of formalin-fixed, paraffin-embedded samples.

Roberts said that the system has a list price of $175,000, and Mike Hrubiak, director of marketing for HTG's automated platforms, told BioArray News that turnaround time for an FFPE sample from slide to result is 24 hours, with less than an hour of hands-on time.

Hrubiak said that HTG began installing the Edge System with clients last month. He said that all systems are configured by default for research use, but the operating systems are bifurcated, meaning that HTG service personnel can switch the same Edge System over to its diagnostics configuration.

HTG this week launched its first assays for use on the Edge, a 47-gene DMPK assay that enables researchers to characterize drug metabolism in pre-clinical studies, and a 32-gene TOA Assay that measures the expression levels of commonly assayed oncogenes (see New Products).

Going forward, Roberts said that the firm will continue to introduce assays for both clinical and research use. In terms of research menu expansion, HTG is developing an assay specific to diffuse large B-cell lymphoma, targeted to cancer researchers, and an immunotherapy assay for use in drug development.

"We'll continue to build out content as demand and our capabilities expand," Roberts said. Labs with the Edge System installed can also order custom plates for specific projects, he noted.

Some of those custom research assays may become available for clinical use, though. In November, HTG announced a partnership with the Centre of Excellence for the Prevention of Organ Failure, or PROOF, at the University of British Columbia in Vancouver to design and commercialize assays that stratify chronic obstructive pulmonary disease patients at increased risk of exacerbations, or lung attacks.

While there is a chance HTG will submit the COPD test to Canadian regulators, Roberts said that for now HTG will focus on getting its first two clinical assays cleared by the FDA and CE-IVD certified, rather than seek clearance for the COPD test in those other markets.

Obsolescence and conversion

Since its founding 15 years ago, HTG has sold products for research use, concentrating on relationships with pharmaceutical companies that use its platform for companion diagnostic development and toxicity studies, as well as academic and government researchers, who make use of its custom array capabilities.

In 2011, though, the firm expanded its target markets to include molecular diagnostics, changing its name to HTG Molecular from High-Throughput Genomics, and working with Merck and the John Wayne Cancer Institute to develop oncology-focused assays (BAN 6/21/2013).

"This is where we see the future of the company," said Roberts, "building out a suite of content specific to molecular diagnostics applications."

Both Roberts and Hrbuiak described the debut of the Edge system last year as "revolutionary" in comparison to its previous platform, the SuperCapella, an assay-reading instrument that the firm has since discontinued. Roberts noted that HTG is offering older customers an obsolescence and conversion plan to move their projects to the Edge.

One factor driving the development of the Edge was a desire to create a system that could support repeatable, accurate assay results. "Molecular assays are highly technique dependent," said Roberts. "There are many steps, and we wanted to reduce those steps to as few as possible."

Another factor though is market competition, both from other next-generation platforms, including Seattle-based Nanostring Technologies' nCounter system, as well as more established approaches, such as real-time PCR.

Hrubiak said that internal studies showed HTG's assays to be "highly correlative" to NanoString's nCounter. Regarding RT-PCR, Roberts portrayed the Edge as an alternative technology.

"Doing RT-PCR is not easy," Roberts said. "Especially for fixed tissues, it is a herculean task."

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