FDA Clears Luminex Corp’s ARIES GBS Assay

Luminex Corporation today announced FDA clearance for the ARIES Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the FDA has cleared for use on the Luminex ARIES Systems. The company has also achieved CE-IVD marking for the ARIES GBS Assay.
 
Infection with Group B Streptococcus (GBS), also known as Streptococcus agalactiae, is a leading cause of neonatal morbidity and mortality, causing meningitis, pneumonia and septicemia in newborns and their mothers. One in four pregnant women are colonized with GBS, with most not exhibiting symptoms; however, it can be transmitted to the newborn during delivery. If not treated, GBS can result in illness or even death in the first week of a newborn’s life. The Centers for Disease Control and Prevention recommends universal GBS testing of women in their 35th-37th week of pregnancy.¹
 
The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus nucleic acid from 18-24 hour Lim broth enriched vaginal-rectal swab specimens obtained from pregnant women. It offers higher sensitivity and increased accuracy when compared to culture, and a reduced turnaround time of two hours after enrichment, compared to 48 hours for culture, with simultaneous STAT and batch testing on the sample to answer ARIES Systems.
 
“We found the Luminex GBS assay to be user friendly, and its streamlined workflow is simpler than most other tests we have evaluated,” said Thomas E. Davis, MD, PhD, Culbertson Professor of Pathology at Indiana University. “Fortunately, most GBS infections can be prevented by antenatal screening and administration of antibiotics during delivery to women determined to be GBS-positive. By providing fast and accurate results, the Luminex GBS assay could support these efforts to keep women and their babies safe.”
 
“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,” said Homi Shamir, president and CEO of Luminex. “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. We expect to accelerate the launch of additional ARIES assays as we move into 2017.” 
 
References
¹About Group B Strep. Centers for Disease Control and Prevention (Internet). Cited 2015 June. Available from: http://www.cdc.gov/groupbstrep/about.