Dublin firm gets EU approval for fast-track meningitis test

Dominic Coyle

A Dublin company has won EU approval for a new test that allows doctors to confirm the potentially fatal bacterial meningitis within an hour.

HiberGene Diagnostics, based in Belfast, says its new testing procedure for Meningococcal disease will deliver results in just a fraction of the time required under current detection methods.

Meningococcal disease can affect people of all ages and, when untreated, can prove fatal in up to 15 per cent of cases, according to HiberGene. The risk of death is highest among young infants and the elderly and those who survive can suffer serious long-term health issues, including brain damage, hearing loss or learning disabilities.

The company, which is targeting the testing for infectious diseases with molecular technology, says its HG Meningococcus test allows for the rapid diagnosis of suspected cases of the disease and earlier treatment. The company says it can detect the Neisseria meningitidis bacterium even at very low levels and with a high degree of accuracy.

The new test was developed at Belfast's Royal Victoria Hospital with funding from the UK's Meningitis Research Foundation and Northern Ireland's NHS Trust, and licensed exclusively to HiberGene.

Chief executive Brendan Farrell said the new test addressed "significant unmet clinical need".

Linda Glennie, head of research and medical information at the Meningitis Research Foundation (MRF) said the European approval showed that long-term investment in research pays off.

“This project began almost a decade ago and it’s great to see it launched today,” she said. “We hope it will help speed up diagnosis of this deadly disease. The 17,000 families affected by meningitis and septicaemia who MRS represents know only too well how important early detection and treatment are.”

The innovation adviser at SC Innovations - part of the Northern Ireland NHS Trust – said the test showed the value of working with practicing clinicians to identify technology opportunities and to develop new products for healthcare.

"These products can help to secure real improvements in healthcare practices globally," Dr David Brownlee said.

HiberGene has been working on bringing this test to market since it was established in 2009. It is the first of a series of tests on which it is working to secure CE mark approval. The company’s pipeline includes test for streptococcus, C Difficile, Nonovirus, MRSA and influenza.