Luminex Receives FDA Clearance for ARIES Bordetella Assay

Texas–based Luminex has gained FDA clearance for the ARIES Bordetella assay for direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.

This is the fourth assay the FDA has cleared since October 2015 for use on Luminex's Aries Systems.

The company has also achieved CE-IVD marking for the Aries Bordetella assay and is preparing to submit its Clostridium difficile assay to the FDA later this month. — Cynthia Jessup