The test meets a significant unmet clinical need and allows physicians to rapidly and accurately test for the presence of meningococcal bacteria, in a near patient setting, ensuring that suspected cases are rapidly diagnosed and the appropriate treatment administered earlier.
Current detection methods for MD include growing the bacteria in a culture medium which can take several days from sample to result, and lacks sensitivity and specificity. By comparison, HiberGene’s test uses LAMP (Loop Mediated Isothermal Amplification), a proven technology for the detection of infectious diseases, which provides results in under an hour.
The test can be performed using a sample of whole blood, cerebrospinal fluid or from a nasopharyngeal swab, and can detect all known pathogenic Neisseria meningitidis serogroups A, B, C, 29E, W135, X, Y, Z, at very low levels with a high degree of accuracy.
The test was developed in the Royal Victoria hospital Belfast with funding received from the Meningitis Research Foundation (MRF) in the UK, and the Health and Social Care (HSC) R+D Division in Northern Ireland. It was subsequently licensed exclusively by HSC Innovations to HiberGene from the Belfast HSC Trust.
Brendan Farrell, CEO of HiberGene, said: “The HG Meningococcus test meets a significant unmet clinical need using advanced and proven technology. Meningococcal disease can be a particularly devastating illness if not treated rapidly, but by utilising the HiberGene product, physicians now have a test which can ensure the best possible care for patients.”
Linda Glennie, Head of Research and Medical Information at MRF said: "this shows that long term investment in research pays off. This project began almost a decade ago and it's great to see it launched today. We hope it will help speed up diagnosis of this deadly disease. The 17,000 families affected by meningitis and septicaemia who MRF represents know only too well how important early detection and treatment are. We look forward to seeing how this test could help save lives in a hospital setting. It's important to remember, however, that such a test is not a substitute for national surveillance to direct public health action. "
Dr. David Brownlee, Innovation Advisor, HSC Innovations, said “this knowledge exchange and commercialization activity between HSC and HiberGene demonstrates 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.”
The launch of the HG Meningococcus test is the first in a series of tests under development by HiberGene. The company is working on a pipeline of new tests for a range of infectious diseases, and plans to launch tests for Group B Streptococcus, C. Difficile and Norovirus in 2016.
Meningococcal disease is an extremely severe disease which, when untreated, can reach fatality rates as high as 15%. Although Meningococcal disease occurs in all age groups and during all seasons, the risk of death is highest among young infants and the elderly. Those who survive can suffer serious long-term deficiencies such as brain damage, hearing loss or learning disabilities.
The test is CE-IVD marked and will be available through a number of national distributors.