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Luminex Gets FDA Clearance for Aries GBS Assay

NEW YORK (GenomeWeb) – Luminex announced today that it has received US Food and Drug Administration approval for its Aries Group B Streptococcus (GBS) assay for antepartum detection of GBS colonization in pregnant women.

The test runs on Luminex's real-time PCR-based sample-to-answer Aries system and is designed to detect GBS nucleic acid from 18 to 24 hour Lim broth enriched vaginal-rectal swab specimens obtained from pregnant women.

According to the company, GBS infection is a leading cause of neonatal morbidity and mortality, causing meningitis, pneumonia, and septicemia in newborns and their mothers. While 1 in 4 pregnant women are colonized with GBS, most do not exhibit symptoms and the infection can be transmitted to newborns during delivery.

"We are delighted to have received our third FDA clearance for an assay indicated for use with our new Arise systems and to launch our first product for antenatal testing," Luminex President and CEO Homi Shamir said in a statement. "We expect to accelerate the launch of additional Aries assays as we move into 2017."

The Aries system and first assay — for herpes simplex virus 1 and 2 — were cleared by the FDA in October 2015. Last summer, the agency approved Aries assays for influenza A/B and respiratory syncytial virus, as well as the lower-throughput Aries M1 system. The Aries systems and assays — including the one for GBS — are also CE-IVD approved in Europe.