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HiberGene Aims to Rapidly Expand Test Menu for New Isothermal Amplification MDx Platform

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NEW YORK (GenomeWeb) – Having secured CE marking for a dedicated instrument to run its isothermal amplification-based bacterial meningitis assay, Ireland's HiberGene Diagnostics is now ready to begin selling the products together in Europe and other areas of the world with a high incidence of the infection.

The Dublin-based firm also plans to rapidly expand the instrument's test menu by adding assays for Group B Streptococcus, Clostridium difficile, and norovirus over the coming year, and is in the midst of a planned $3.5 million to $4 million financing round to support these efforts, HiberGene Chairman and CEO Brendan Farrell told GenomeWeb last week.

HiberGene was founded in 2009 based on research performed at the Royal Victoria Hospital in Belfast demonstrating that loop-mediated isothermal amplification could be used to directly detect bacterial meningitis in patient samples.

In August 2014 the firm secured a non-exclusive license from Eiken Chemical to use LAMP in diagnostic products for infectious disease. And in early 2015, HiberGene raised €1.9 million ($2.1 million at the time) in a Series A financing round to begin transferring the meningitis assay from Royal Victoria Hospital to a commercial product.

Earlier this month, HiberGene garnered CE marking for the meningitis assay, HG Meningococcus, which detects the DNA of all known Neisseria meningitidis subgroups, and a few weeks later it obtained CE marking for the companion molecular testing instrument, dubbed the HG Swift.

The platform is a modified and optimized version of an instrument called the Genie III manufactured by UK firm OptiGene. One of the attractive features of isothermal amplification-based molecular diagnostics is that they do not require expensive instrumentation to run, like qPCR does. In line with this, HiberGene's Farrell told GenomeWeb that the company plans to sell HG Swift for about $8,000, but noted that it contains several bells and whistles that put it a step above most platforms running LAMP assays.

For instance, the platform can run four different tests simultaneously – not an important feature currently, since HiberGene only has the meningitis test, but eventually an attractive option once the company expands its test menu and customers want to perform on-demand testing.

Further, it features touch-screen technology for operation, and provides real-time graphics of reaction kinetics so users can see the increase in fluorescence that corresponds to successful target amplification and a positive result.

The instrument also has a small footprint, about 250 mm by 150 mm, weighs less than two kilograms, and although it requires electricity to operate for long periods of time, it does have a rechargeable lithium-polymer battery that can support operation for a day. These last few features are particularly valuable in the developing world, where portability is crucial and power outages are common.

"If there's a power outage it just continues to run without any difficulty," Farrell said. "In fact if you unplugged it in the middle of a run, it just keeps going. Power outages are not a big deal in the developed world, but in places like South Africa, it could be an issue. It's also Wi-Fi- and Bluetooth-enabled, so in theory you could send the results from the instrument to somebody's cell phone."

Given these specifications, the HG Swift could be an attractive option for decentralized testing in the developing world, a market that HiberGene is pursuing along with physician office labs and small hospital labs in the UK and other countries that recognize the CE mark.

"We have a very good distributor in South Africa who's just placed its first order for the meningococcus test and [the instrument]," Farrell said. "The incidence of meningitis there is high due to overcrowding in townships, so that's sort of our first venture into Africa. Farther north some of the surrounding countries are also interested in distributing the product, and [there is] a meningitis belt right across sub-Saharan Africa. Whether that's accessible for this kind of technology, I'd probably question that, but nonetheless, with the simplicity of the instrument, there is the possibility."

In the UK and Europe, Farrell admitted that it will be "challenging" for HiberGene to immediately sell its instrument with only one test on it, even though the price point is low. For this reason the company is now moving to rapidly fill out the test menu.

"We're pushing for GBS to be out there at the end of the first quarter. This will be followed by C. difficile at the end of the second quarter [and] norovirus probably in fourth quarter. So hopefully we'll have four tests out at the end of next year."

HiberGene also plans to pursue regulatory clearance in the US, and is just beginning the process now for the HG Swift and HG Meningococcus. It will follow suit for each of its future assays as they receive CE marking. Farrell said that he anticipates the platform would garner a moderately complex designation under CLIA in the US.

To fund these efforts, HiberGene is in the middle of a Series D financing round targeting $3.5 million to $4 million, of which the firm has secured about $1.7 million, Farrell said.

He added that the first publications and scientific posters describing clinical validation of HiberGene's tests are expected throughout next year, beginning with a poster on the meningitis assay at April's European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam.

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