A capital injection of €2m will allow Dublin company HiberGene Diagnostics to forge ahead with plans to launch a revolutionary rapid diagnostic test for meningitis this year.
“HiberGene’s test gives a positive result in less that 10 minutes, while previously available tests for meningitis take one-and-a-half to two hours to give results,’’ says chief executive and co-founder Brendan Farrell. “It is faster and simpler to use than other tests and offers a major advancement in detection.”
Scheduled for launch in the autumn, the meningitis test is one of two developed by the company, which is a spin out of the Royal Victoria Hospital in Belfast. The second test is for Group B streptococcus (GBS) and is set to go on the market at the end of the year.
The recently announced €2m investment includes €1.4m from private investors, €500,000 from Kernel Capital though the Bank of Ireland MedTech Accelerator Fund, and €200,000 from Enterprise Ireland. This funding is being used to commercialise both tests and the company has recruited five employees. Mr Farrell is in the process of finding a third-party manufacturer to produce the test kits.
A 30-year veteran of the diagnostics sector, Mr Farrell, who previously managed Trinity Biotech and Crescent Diagnostics, heard about the development of meningitis and GBS tests at Belfast hospital in 2009. He joined with former Arcon chief executive Peter Kidney and three doctors in setting up the firm to develop tests for infectious diseases.
Over the last five years, HiberGene has worked on fundraising, securing exclusive licences from the Royal Victoria Hospital for the tests, and licensing LAMP technology from Eiken Chemical in Japan. This piece of technology drives the tests and is responsible for the speed of testing, Mr Farrell says.
Both products have since been trialled and HiberGene secured a US patent on the meningitis test in 2012; a patent is pending in Europe. Following the signing of the licence agreements last year, HiberGene is now working on commmercialising the tests and securing CE mark recognition.
The tests are devised for use by hospital laboratories as well as near-patient settings such as emergency rooms and delivery wards. HiberGene is specifically targeting small and medium- sized hospitals rather than large hospitals with high volumes of tests.
Mr Farrell says there is an unmet clinical need for rapid and accurate testing for both of its products. “Meningitis affects 1.2m people every year, with one in 10 of these cases resulting in fatality,” he says.
The GBS test addresses an even larger market. “GBS can pass from pregnant women to children during labour, with fatal consequences in 6% of cases,” says Mr Farrell. “In the UK and France, testing is compulsory for women in labour. The test used at present is a culture, which takes 48 hours. The HiberGene test is a significant advancement.”
The company is now making plans to sell through distributors to Germany, France, Italy, Spain, and Britain. It plans to launch in the US in 2016, once it has secured Federal Drug Administration approval.
The next step this year will be to embark on a second fundraising round. HiberGene is seeking a further €2.5m to develop further tests for infectious diseases using the LAMP technology. Mr Farrell says the next products will be used to test for MRSA and sexually transmitted diseases. In the long term, HiberGene aims to establish itself as a significant player in the infectious disease testing sector.