With PHA funding, Belfast’s meningitis diagnostic test moves closer to market

Funding from the Health and Social Care Research and Development (HSC R&D) division of the Public Health Agency (PHA) has helped the Belfast Health and Social Care Trust (BHSCT) create a new meningitis diagnostic test. The test has been licensed to HiberGene Diagnostics Ltd, a start-up client company of NovaUCD, the Innovation and Technology Transfer Centre, Dublin.

Diagnosis of meningitis is notoriously difficult. Initial ambiguous flu-like symptoms make early diagnosis very challenging. Standard laboratory tests take at least 24 hours, but the new test provides a reliable diagnosis in less than one hour to allow earlier confirmation and treatment.

The new test was developed by scientists in the Royal Victoria Hospital laboratories and uses an emerging molecular method known as loop-mediated isothermal amplification (LAMP), which is a form of rapid polymerase chain reaction, to provide the result. The new test has the potential to be used in emergency departments instead of hospital laboratories and is currently being evaluated at the Royal Belfast Hospital for Sick Children.

Consultant Paediatrician Professor Mike Shields led the original research project, which was supported by grants from the Meningitis Research Foundation and the HSC R&D division of the PHA.

Professor Shields said: “Meningitis presents a clinical challenge for the emergency department doctor because the patient’s symptoms can be non-specific. No doctor wants to send a seriously sick child home, which is why this new diagnostic test holds such promise. When this test is available, it will have the potential to save many lives.”

Dr Michael Neely, Assistant Director of Public Health at the PHA, said: “I am delighted that this research has led to the development of such an important diagnostic test. It is great to see innovative technology deriving from the investment of our research funding being brought to market for the benefit of our healthcare system. The work of the Regional Virus Laboratory team, Dr Peter Coyle, Dr Derek Fairley and Mr James McKenna has been key to the development of this award-winning technology. The HSC R&D division has further invested in this work through the recent award of a HSC R&D doctoral fellowship to Dr Thomas Bourke, and we look forward to seeing more exciting developments from the team.”

Brendan Farrell, CEO of HiberGene Diagnostics, said: “We are particularly pleased to have secured exclusive rights to the meningitis test from the Belfast Trust. Clinical validation of the test has shown a sensitivity of 100% and a specificity of 99.7%, which is excellent. HiberGene plans to commercialise the test in the first half of 2012 and is already in discussions with a number of potential distribution partners in the USA and Europe. We look forward to further collaboration with the Trust.”

HiberGene is also currently working on a series of additional molecular assays to rapidly detect pathogenic microorganisms.

HSC Innovations, the technology transfer office for the Northern Ireland Health and Social Care service, patented the invention and facilitated the deal with HiberGene.
Professor Ian Young, Director of Research at Belfast Trust, said: “This diagnostic test is an excellent example of the high-quality research that is conducted by doctors, nurses and scientists in the Belfast Trust. I am particularly pleased that HSC Innovations has secured patent protection for this diagnostic test, making it an appealing proposition to a commercial partner. We look forward to the test reaching the market and improving patient care.”