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FDA approves Luminex's PCR test for Group B strep in pregnant women

MDBR Staff Writer Published 05 January 2017

The US Food and Drug Administration (FDA) has approved Luminex's Aries Group B Streptococcus (GBS) assay for antepartum detection of GBS colonization in pregnant women.

The assay, which has also received CE-IVD mark approval, is the third test that was cleared by FDA for use on the Luminex Aries systems.

Infection with Group B Streptococcus or Streptococcus agalactiae will result in neonatal morbidity and mortality, causing meningitis, pneumonia and septicemia in newborns and their mothers.

The assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test, which will detect Group B Streptococcus nucleic acid from 18-24 hour Lim broth enriched vaginal-rectal swab specimens secured from pregnant women.

According to the firm, the test provides higher sensitivity and increased accuracy compared against culture, as well as reduced turnaround time of two hours after enrichment compared to 48 hours for culture.

Aries systems are sample to answer molecular diagnostic systems, which use internal barcode scanning and other advanced features to reduce operator errors.

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.”


Image: Aries GBS assay is a real-time PCR-based qualitative in vitro diagnostic test. Photo: courtesy of Luminex Corporation/PRNewswire.