FDA clears Luminex’s ARIES GBS assay for GBS colonisation detection in pregnant women
The US Food and Drug Administration (FDA) has granted clearance for medical technology firm Luminex’s ARIES Group B Streptococcus (GBS) assay to detect GBS colonisation in pregnant women.
Also known as Streptococcus agalactiae, GBS forms colonies in one in four pregnant women, and if left untreated, can be transmitted to a newborn during labour and delivery, potentially resulting in septicemia, pneumonia or meningitis for both the mother and the newborn.
The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test which sensitively and accurately detects Group B Streptococcus nucleic acid from 18-24 hour Lim broth enriched vaginal-rectal swab specimens derived from pregnant women.
Designed to fit seamlessly into a lean laboratory environment, ARIES enhances laboratory performance and increases efficiency by using internal barcode scanning and other advanced features to minimise operator errors.
The sample to answer system also features two independent magazine modules that support from one to six cassettes each, enabling STAT and batch testing.
Luminex president and CEO Homi Shamir said: "The high-level of sensitivity and accuracy of the ARIES GBS Assay over culture tests will aid in the diagnosis of more patients, ensure better quality of care, and increase patient and clinician confidence in the results.
"We are delighted to have received our third FDA clearance for an assay indicated for use with our new ARIES Systems and to launch our first product for antenatal testing, increasing the value we can provide to clinicians, women, and children at a time when their need is at its greatest.”
The company has also obtained CE-IVD mark for ARIES GBS Assay.