Luminex wins FDA nod to test for dangerous pregnancy infection



Luminex Aries GBS assay [Image courtesy of Luminex]

Luminex continues to rack up FDA clearances for assays to use in its Aries systems.

The Austin, Texas–based company said Wednesday that FDA has cleared an Aries assay for group B streptococcus. It’s the third assay FDA has cleared for use with Luminex’s Aries systems.

The GBS assay has also received a CE-IVD marking. Luminex plans to launch additional Aries assays this year. Aries systems are meant to increase laboratory efficiency and ensure result accuracy.

One in four pregnant women carries GBS. If not treated with antibiotics, it could cause illness or death of a newborn during the child’s first days out of the womb. The U.S. Centers for Disease Control and Prevention recommends universal testing for group B streptococcus between the 35th and 37th week of pregnancy.

Luminex boasts that the Aries GBS assay offers higher sensitivity and increased accuracy detecting group B streptococcus from vaginal-rectal swab specimens when compared to traditional culture methods. The assay for Aries also has a reduced turnaround time of two hours after enrichment, compared to 48 hours for culture.

“We found the Luminex GBS assay to be user friendly, and its streamlined workflow is simpler than most other tests we have evaluated,” Dr. Thomas E. Davis, a pathology professor at Indiana University, said in a Luminex news release.

“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,” Davis said.

Aries system assets include internal barcode scanning and other features to minimize operator errors. They have independent modules supporting one to six cassettes, with an integrated touchscreen PC.

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