HiberGene Diagnostics' rapid test for meningococcal disease gains CE mark

HiberGene Diagnostics announced Tuesday that HG Meningococcus, a rapid test for meningococcal disease, gained the CE mark. The test, which can diagnose bacterial meningitis in less than one hour, "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," the company said.

According to HiberGene, HG Meningococcus, which uses loop mediated isothermal amplification, can be performed using a nasopharyngeal swab, or a sample of whole blood or cerebrospinal fluid. The company added that the test 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 and was subsequently licensed by HSC Innovations to HiberGene from the Belfast Health and Social Care Trust.

HiberGene noted that it is developing a pipeline of tests for a range of infectious diseases, and plans to launch tests for Group B Streptococcus, Clostridium difficile and Norovirus next year.

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