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Luminex gets FDA approval for ARIES Bordetella assay

Published 04 May 2017

Luminex has secured FDA approval 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, is preparing to submit its Clostridium difficile assay to the FDA later this month, and is in the process of completing a Group A Streptococcus clinical trial as it seeks to further expand its ARIES menu.

Pertussis, commonly known as whooping cough, is a contagious respiratory disease caused by the organism Bordetella pertussis. This infection can lead to life-threatening complications in infants and young children.

Worldwide, there are an estimated 16 million cases of pertussis and about 195,000 deaths per year. The CDC states that there has been an increase in the number of reported cases of pertussis in the United States since the 1980s. 

According to the CDC, "Early signs and symptoms of pertussis are often non-specific, making it difficult to determine clinically who has pertussis in the earliest stages. However, only patients with signs and symptoms consistent with pertussis should be tested by PCR to confirm the diagnosis."

They note that testing asymptomatic persons should be avoided due to the likelihood of obtaining false-positive results. The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR)-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.

John W. Longshore Ph.D., Director of Molecular Pathology at the Carolinas HealthCare System, commented: "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."

ARIES® Systems automate all aspects of testing, from sample preparation through analysis, providing answers in less than 2 hours with minimal hands-on time. The ARIES® Bordetella Assay is part of Luminex's comprehensive respiratory testing menu that also includes: ARIES Flu A/B & RSV, VERIGENE® RP Flex, and NxTAG® RPP.

"The high specificity of our Bordetella Assay combined with the rapid results provided by the ARIES® platform should lead to more positive patient outcomes," according to Homi Shamir, President and Chief Executive Officer of Luminex. "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."

ARIES Systems are sample to answer molecular diagnostic systems designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory environment. ARIES® uses internal barcode scanning and other advanced features to minimize operator errors.

Independent modules support from one to six cassettes, allowing for both STAT and batch testing of IVD assays and laboratory developed tests (LDTs) with MultiCode® Reagents when using a universal assay protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space.



Source: Company Press Release