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HiberGene Receives CE Mark for Group B Strep Test

NEW YORK (GenomeWeb) – Irish molecular diagnostics firm HiberGene announced today that it has received CE marking for its HG Group B Streptococcus (GBS) test for the detection of strep infection in pregnant women using rectovaginal swabs.

The assay uses loop-mediated isothermal amplification to detect Streptococcus agalactiae infection — a common cause of neonatal meningitis that can also lead to septicemia and pneumonia — in under an hour. The test was cleared in Europe this summer for use with cerebrospinal fluid and whole blood from newborns, and enriched broth from pregnant women.

All of HiberGene's assays are designed to run on the company's HG Swift instrument, including its CE marked bacterial meningitis test.

"The ability to test for GBS in pregnant women with a simple swab will significantly improve patient care by returning a rapid test result," HiberGene CEO Brendan Farrell said in a statement. "This will mean that intrapartum testing can be a reality and will enable healthcare professionals to tailor a care plan to ensure correct treatment during labor."