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Irish MDx Firm HiberGene Raises $2.1M to Market Meningitis, Strep Tests


NEW YORK (GenomeWeb) – Irish molecular diagnostics startup HiberGene has raised €1.9 million ($2.1 million) in a Series A financing round, HiberGene CEO Brendan Farrell told GenomeWeb last week.

Dublin-based HiberGene will use the funding to support several recently hired employees, who are charged with helping to commercialize the company's first two products: molecular assays for meningococcal meningitis and group B streptococcus using loop-mediated isothermal amplification (LAMP) technology.

Farrell said that the funding will also help HiberGene transfer the assays from the Royal Victoria Hospital in Belfast, where they were developed, to a third-party manufacturer with the goal of commercializing the tests in EU territories by the third quarter of this year.

"We'll start with CE marking of those products, and then we'd seek FDA approval of those," Farrell said. "That will be done through independent distributors, whom we're already interviewing. For the foreseeable future we will not have our own direct sales force in place, but will operate through third-party distributors."

HiberGene spun out of University College Dublin in 2009. In 2011 it exclusively licensed patent applications surrounding its meningitis test from Belfast Health and Social Care Trust after doctors at BHSCT's Royal Victoria Hospital discovered how LAMP could be used to detect the presence of Neisseria meningitides, the primary causative agent of meningococcal meningitis.

The company also subsequently licensed the rights to the GBS assay from BHSCT, and in August 2013 then-CEO Tony Hill told GenomeWeb that the company hoped to commercialize these products in Europe by the end of that year and in the US by the end of 2014.

Those plans never came to fruition, however, although HiberGene did hit an important milestone last August when it secured a non-exclusive license to use Eiken Chemical's LAMP technology in its commercial molecular diagnostic products.

Farrell told GenomeWeb last week that the reason for the delay in commercialization was simply a lack of funding.

"Without the funding we just couldn't do anything," Farrell said. "It was a question of not managing to get the funding in place as quickly as we thought."

The Series A financing round is now essentially complete, Farrell said, with potential additional funding from a government agency waiting in the wings. Should that funding come through, HiberGene will have closed the round with about €2 million, but it currently stands at €1.9 million. Of that amount, €1.4 million came from private individuals, Farrell said, with the balance provided by the Bank of Ireland seed capital fund.

HiberGene will enter a rapidly crowding market for point-of-care infectious disease MDx tests based on isothermal amplification. Assays from companies such as Meridian Bioscience, Quidel, and Alere are already on the market, with Meridian having the largest head start with its illumigene brand test for Clostridium difficile receiving US Food and Drug Administration clearance in 2010.

Despite being an early player, Meridian has had recent difficulties selling its C. difficile test, with competing assays from a number of molecular diagnostic firms eating into its market share. Despite this, Meridian has begun to diversify its test menu by adding assays for Bordetella pertussis, Group A strep, and Group B strep, which the company said last week helped drive a 7 percent year-over-year increase in first quarter revenues.

"In some respects we would be using Meridian as kind of a template, because they have a license to the LAMP technology for infectious disease," Farrell said. "Our goal is to kind of mirror what they're doing, in a sense, but also perhaps improve on what they're doing, and also have a somewhat different menu of products."

For instance, HiberGene believes its Group B strep test will be "significantly faster" than Meridian's. Since they both use LAMP, the actual assay times would be similar, in the range of a half-hour, but Meridian's GBS requires a pre-incubation step of several hours "before you actually get around to performing the molecular test," Farrell noted. "We would not have that incubation period," and as such, the company hopes to be able to provide sample-to-answer testing in under an hour — HiberGene's tests would necessitate a standard manual nucleic acid extraction and purification step.

Meridian also doesn't have an assay for meningitis, and its tests are performed using turbidimetry, while HiberGene's use a fluorescence readout, "which gives us greater sensitivity," Farrell said. "And we will have a different menu of products, though some will overlap. We also have an interest in C. diff, for instance, and they also have a Group B strep test."

Meridian's tests have also been validated more thoroughly in peer-reviewed publications, although Royal Victoria Hospital has published a few studies on the HiberGene meningitis and Group B strep assays. Farrell said that researchers at the hospital also recently submitted a study for publication in a major medical journal that validates the meningitis assay using throat and nasal swabs.

If all goes according to plan, HiberGene will have its first two products on the market in the EU in the third quarter. Ideally, FDA clearance would follow about a year after that, although Farrell cautioned that this timeline is difficult to predict.

The company also is beginning work on a number of other tests, including for pneumococcal meningitis, methicillin-resistant Staphylococcus aureus, the aforementioned C. diff, influenza A/B, and respiratory syncytial virus.

"In order to get to the development of a next round of products, we're doing a second round of fundraising that will kick off next month, a Series B funding [targeting] around  €2.5 million," Farrell said.