Canada-based diagnostic devices maker GenePOC has introduced its GenePOC Group B Streptococcus (GBS) Direct Swab (DS) molecular test in Europe to reduce the risk of transmission from mother to newborn.
GenePOC GBS DS is designed as a sensitive and accurate qualitative in-vitro diagnostic test to identify GBS from direct vaginal/rectal swab samples at intrapartum.
The point-of-care test will provide a precise assessment of the GBS colonisation status of the mother at the time of delivery, allowing better control of transmission risk, as well as lowering mortality and morbidity.
GenePOC CEO Patrice Allibert said: “Our goal is to work closely with our distribution partners to improve the standard of care while decreasing the occurrence of early onset Group B Streptococcal disease in infants.
“The GenePOC offer is a breakthrough solution for testing GBS carriage while the mother is in labour.
“Compared to alternatives already on the market, we excel in providing actionable and highly reliable results to clinicians and women.”
The easy-to-use test enables analysis of up to eight samples in a single run and comes with an integrated process control to check sample processing and quality.
Intended to optimise antibiotic stewardship, the new test is indicated for use on the revogene device that obtained CE-Mark as well as approval from the US Food and Drug Administration (FDA).
Revogene is an automated instrument developed to test single-use proprietary microfluidic cartridges or PIEs using fluorescence-based real-time polymerase chain reaction (PCR) to offer an accurate diagnosis.