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HiberGene receives CE-IVD mark approval for meningitis test

HiberGene Diagnostics has received CE-IVD mark approval for its HG Meningococcus test, which enables physicians to discover the presence of meningococcal bacteria in patients.

HG Meningococcus is a rapid test that will be used to identify the severe form of bacterial meningitis, Meningococcal disease (MD), caused by the bacterium Neisseria meningitidis.

The new test deploys Loop Mediated Isothermal Amplification (LAMP) technology, which helps in the detection of infectious diseases and provides results within one hour.

HiberGene’s test can be carried out using a sample from a nasopharyngeal swab, whole blood and cerebrospinal fluid to 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.

UK’s Meningitis Research Foundation (MRF) and Northern Ireland’s Social Care (HSC) R+D Division have provided fund to develop the test at Royal Victoria hospital, Belfast.

The test was subsequently licensed exclusively by HSC Innovations to HiberGene from the Belfast HSC Trust.

HiberGene Diagnostics CEO Brendan Farrell 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."

HiberGene is also involved in developing new tests for a wide range of infectious diseases, and plans to introduce tests for Group B Streptococcus, C. difficile and Norovirus in the next year.