Luminex Corporation has commenced clinical and analytical studies to evaluate the company's ARIES Group B Streptococcus (GBS) Assay.
"We continue to build momentum in our commercial launch schedule for the ARIES platform with the start of clinical trials for GBS, the third assay in the ARIES pipeline," said Homi Shamir, president and chief executive officer f Luminex. "The progression of our ARIES menu with assays that are important to patient care continues and the Group B Strep assay is a key contributor due to the high prevalence and potentially serious or life threatening consequences to newborns."
The clinical trials for the ARIES GBS Assay are being conducted at several clinical laboratories in the US, and Luminex still expects its FDA submission for the ARIES platform and ARIES HSV 1&2 Assay to occur in the summer of 2015.
One in four pregnant women are colonized with Group B Streptococcus (GBS), also known as Streptococcus agalactiae. If not treated, GBS can be transmitted to a newborn during labor and delivery, potentially resulting in sepsis, pneumonia, or meningitis. Fortunately, most GBS infections can be prevented through recommended prenatal screening and, if positive, administration of antibiotic treatment during delivery.
ARIES is a sample to answer system designed to deliver superior laboratory performance, increase laboratory efficiency, and fit seamlessly into today's lean laboratory environment. ARIES uses internal barcode scanning and other advanced features to minimize operator errors. Two independent magazine modules support from one to six cassettes each, allowing for STAT and Batch testing. Simultaneous IVD and Laboratory Developed Tests (LDTs) operate through a common Universal Assay Protocol. An integrated PC eliminates the need for a separate computer, stand-alone keyboard, and mouse, thus maximizing valuable bench space.
Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP open-architecture multi-analyte platform, MultiCode real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers.