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HiberGene Receives CE Mark for Meningitis MDx

NEW YORK (GenomeWeb) – Dublin, Ireland-based HiberGene Diagnostics announced today the CE-IVD marking and launch of its first molecular assay, a test for bacterial meningitis.

Called HG Meningococcus, the test uses loop-mediated isothermal amplification to detect the DNA of all known pathogenic Neisseria meningitidis serogroups, and "meets a significant unmet clinical need using advanced and proven technology," HiberGene CEO Brendan Farrell said in a statement.

The company said the test is the first in a series of forthcoming infectious disease assays. The firm plans to launch Group B Streptococcus, Clostridium difficile, and norovirus tests in 2016, assisted by the $2.1 million in Series A financing it raised in January. The tests are estimated to run in about a half hour, as reported by GenomeWeb.   

Untreated meningitis can have fatality rates as high as 15 percent, with the risk of death being highest for infants and the elderly. "Meningococcal disease can be a particularly devastating illness if not treated rapidly, but by utilizing the HiberGene product, physicians now have a test which can ensure the best possible care for patients," Farrell said.

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