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DUBLIN, Ireland, Jan. 12, 2017 -- A joint study conducted by Dublin-based molecular diagnostics manufacturer HiberGene and the National Maternity Hospital (NMH), Dublin has found HiberGene’s Group B Streptococcus (GBS) to be an accurate and rapid alternative to testing with the current gold standard microbiological culture method.
The results from the study showed that HiberGene’s GBS Test was able to accurately detect the presence of GBS in pregnant women, and found that 19 percent of those tested carried GBS. The blinded study involved sampling and testing of 400 pregnant women, with microbiological testing performed at NMH and molecular testing performed independently at HiberGene’s R&D facility.
The gold standard technique for identification of GBS takes 48 hours to run in a dedicated microbiology lab, and is not suitable for real time detection of infection during childbirth. HiberGene’s molecular test, in contrast, returns a result in approximately one hour and can be performed with minimal laboratory facilities.
Approximately 20 to 30 percent of all pregnant women are colonized with GBS bacteria, typically with no symptoms. If passed on to the newborn during delivery, GBS can have potentially fatal consequences, including meningitis and sepsis. In Ireland, around 50 babies per year are affected, and in common with many other countries, no routine screening for GBS in pregnancy is offered. Instead, a risk-based evaluation is performed in an attempt to identify women who require administration of antibiotics during labour to prevent transmission.
NMH Consultant Microbiologist, Dr Susan Knowles, said of the study: “The current risk-based evaluation for GBS means that some pregnant women who do not have GBS are given IV antibiotics in labour, while some other GBS colonised women without obvious risk factors are not. The speed and accuracy of HiberGene’s test allows for important clinical decisions on antibiotic administration to be taken on the basis of real-time test data.”
Brendan Farrell, CEO of HiberGene, said: “The excellent results obtained in this study demonstrate the clinical value of our HG GBS test. Not only is it highly accurate, but the speed to result allows for testing of women in labour, and therapeutic intervention in a timely manner to reduce the likelihood of infection in the newborn baby.”
For more information, please contact: Tony Stephenson Exitus Communications Tel: +44 (0)7899 796655 Email: [email protected] Brendan Farrell Chairman & CEO HiberGene Diagnostics Limited Email: [email protected]
