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HiberGene to Launch Three Multiplex Infectious Disease Tests by Year End; Seeks US Partner

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NEW YORK (GenomeWeb) – HiberGene Diagnostics, an Irish molecular test provider, plans to debut a trio of new multiplex assays for influenza, respiratory syncytial virus, and sexually transmitted diseases, by the end of the year.

The Dublin-based company also aims to raise up to €5 million ($6 million) this year to support additions to its R&D and sales and marketing teams. HiberGene, which has achieved CE-IVD marks for its entire menu of infectious disease tests, is also eyeing international expansion, looking to enter both the US and Chinese clinical markets with the help of partners.

"We are at the early stages of commercialization," said CEO Brendan Farrell. "In diagnostics, you need to have a menu of tests before you start to get traction," he said. "Our sales are modest at the moment, but they will climb rapidly as we expand our test menu and as we expand our geographic coverage."

HiberGene last month announced that it had secured a CE-IVD mark for its HG Pneumo/Meningo Combo test, an assay for the combined detection of meningococcal and pneumococcal meningitis in untreated cerebrospinal fluid. The test relies on HiberGene's core technology: real-time, loop-mediated isothermal amplification, or LAMP.

Samples are read using its benchtop HG Swift instrument, which retails at about €8,000 and has a small footprint of about 250 mm by 150 mm, weighing less than two kilograms. According to Farrell, the size and ease of use of the instrument make it ideal for smaller, simplified laboratories. Individual tests cost labs around €25, Farrell said, and the firm claims its platform can produce results in an hour.

In addition to expanding its menu, the HG Pneumo/Meningo Combo test is the first of HiberGene's assays to test for two indications, a "technological advance" for the company that underlies the three tests it has in development: HG Flu A/B, HG RSV A/B, and its STD test, which will be used to detect gonorrhea and/or chlamydia in urine or female swab samples.

"They are all coming out of R&D toward the latter end of this year," said Farrell.

HiberGene was established in 2009, is privately held, and employs 25 people. The firm's technology is based on research performed at the Royal Victoria Hospital in Belfast that showed that LAMP could be used to directly detect bacterial meningitis. It later secured a license to the technology in 2014 from Eiken Chemical, a Japanese company that owns the rights to the LAMP approach.

It currently sells four other assays in addition to the new HG Pneumo/Meningo Combo test: HG Meningococcus Direct CSF for the detection of Neisseria meningitidis, launched in September 2017; HG C. difficile, for the detection of the bacterium Clostridium difficile in stool samples, launched in December 2016; its HG Group B Streptococcus test, for the diagnosis of GBS in pregnant women and infants, launched in July 2016; and HG Meningococcus, a test for a severe form of bacterial meningitis, Meningococcal disease, which it introduced in December 2015.

Much of the work that enabled the creation of its most recent test, the HG Pneumo/Meningo Combo, was supported by a €6.7 million round of Series B financing that HiberGene closed in April 2017. That money also allowed the company to expand its distribution network: Farrell said that HiberGene's assays are now available via distributors in 40 countries. HiberGene had previously closed a Series A round of about €2.1 million to support the start of its business.

To support the development and launch of its three new assays and commercialization activities, Farrell said that HiberGene aims to raise around €5 million by year end, and has commitments in place for half of that figure. Farrell said that the funding should also allow HiberGene to hire around 10 people in R&D and marketing. All activities are concentrated in its office in Dublin.

One of HiberGene's investors is Medcaptain, a Shenzhen, China-based in vitro diagnostics company. Farrell said that Medcaptain invested €250,000 in its Series B round and has pledged €500,000 to the current round.

Medcaptain is also seeking to have the HG Swift system approved for clinical use by the China Food and Drug Administration, along with HiberGene's HG Group B Streptococcus test. Farrell noted that China would present a sizable market opportunity for HiberGene should its test become a routine part of intrapartum care there. "There are 17 million births per year in China," he said. "It's a big-volume market."

Culture is typically performed on women during their pregnancy to test for GBS, whereas HiberGene's test is performed while the woman is in labor, as it can produce results in less than an hour. If the woman is found to be colonized by GBS, she is put on intravenous antibiotics that are circulated to the child's bloodstream prior to birth. "That way, the baby is protected," he said.

Indeed, culture remains one of the dominant approaches for infectious disease testing in general, Farrell added, consisting of about 35 percent of the market. Enzyme-linked immunosorbent assays comprise half of the market, he estimated, while molecular tests, like those offered by HiberGene, amount to just 15 percent. The latter are offered by a diverse group of companies targeting the same indications as HiberGene, such as Luminex, which sells its Aries Group B Streptococcus assay for antepartum detection of GBS colonization in pregnant women, or BioMérieux, which sells the BioFire FilmArray panel for meningitis and encephalitis.

Farrell believes that molecular approaches such as those offered by HiberGene, Luminex, or BioMérieux will eventually "cannibalize" culture and ELISA-based infectious disease testing.

And while China represents a new market for HiberGene, the company has not lost sight of the US market opportunity, roughly 35 percent of the global molecular testing market.

To date, HiberGene has had "very preliminary" discussions with the US Food and Drug Administration, as well as with potential partners, according to Farrell. That is set to change, however, as the company seeks a partner before commencing trials ahead of an FDA submission.

"We are now seeking a partner ... so that we can start our FDA trials knowing that we have a distribution partner in place," Farrell said. He said that HiberGene expects market entry in the US, as well as China, by the end of 2019.

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