NEW YORK (GenomeWeb) – Luminex said today that it has received clearance from the US Food and Drug Administration for its Aries Bordetella Assay for direct detection and identification of Bordetella pertussis and Bordetella parapertussis.
The Aries Bordetella Assay identifies bacterial nucleic acids in nasopharyngeal swab specimens obtained from people suspected of having respiratory tract infections attributable to B. pertussis and B. parapertussis, Luminex said. The assay — a real-time PCR-based qualitative in vitro diagnostic test — targets the pertussis toxin promoter and IS1001 repeat sequence in the genomes of the two bacteria. It is indicated for use with Aries Systems that automate testing, from sample preparation through analysis, providing answers in less than 2 hours with minimal hands-on time, the company added.
"The high specificity of our Bordetella Assay combined with the rapid results provided by the Aries platform should lead to more positive patient outcomes," Luminex President and CEO Homi Shamir said in a statement. "The Aries Bordetella Assay is a cost-effective option for lower-volume labs desiring high-performance molecular testing, and is part of a growing menu of tests from Luminex that can be adapted to fit the respiratory testing needs of any clinic."
The company has already achieved CE marking for its Bordetella assay. It is the fourth assay to be cleared by the FDA since October 2015 for use on the Aries system.
The firm said that it is also preparing to submit a Clostridium difficile assay to the FDA later this month, and that it is in the process of completing a Group A Streptococcus clinical trial.
The Aries Bordetella Assay is part of the Luminex respiratory testing menu that also includes Aries Flu A/B & RSV, Verigene RP Flex, and NxTag RPP.