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FDA clearance for Aries Bordetella assay

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June 5, 2017Luminex received FDA clearance for the Aries Bordetella Assay for direct detection and identification of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The company has also achieved CE-IVD marking for the Aries Bordetella Assay, is preparing to submit its Clostridium difficile assay to the FDA, and is in the process of completing a group A Streptococcus clinical trial.

The Aries Bordetella Assay is a real-time polymerase chain reaction–based qualitative in vitro diagnostic test that targets the pertussis toxin (ptxA) promoter and IS1001 repeat sequence in the genomes of B. pertussis and B. parapertussis, respectively.

“Healthcare systems like ours will benefit from having a molecular assay for B. pertussis and B. parapertussis available in a moderate complexity sample to answer format. The newly cleared Bordetella assay from Luminex should aid in efficient patient diagnosis and B. pertussis reporting to the CDC,” John W. Longshore, PhD, director of molecular pathology, Carolinas HealthCare System, said in a statement.

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August 2017—Luminex received FDA clearance for the Aries Bordetella Assay for direct detection and identification of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.

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