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Luminex receives FDA clearance for ARIES Group A Strep assay

Published 01 November 2017

Luminex announced that it has received FDA clearance for the ARIES Group A Strep assay, a moderate complexity, sample to answer test for the direct detection of Streptococcus pyogenes from throat swab specimens using the ARIES® System.

This is the sixth assay the FDA has cleared for use on Luminex's ARIES® Systems in the last 24 months.

Fast and accurate diagnosis of Group A Streptococcus infections is critical to ensuring that appropriate antibiotic therapy is started promptly. For example, accurate diagnosis of Group A β-hemolytic Streptococcus pyogenes is crucial for determining the optimal treatment since physical examination alone is not sufficient to distinguish between pharyngitis caused by Group A β-hemolytic Streptococcus pyogenes and viral pharyngitis, or non-GAS bacterial organisms such as Fusobacterium necrophorum.

Invasive cases of this infection lead to as many as 1,600 deaths in the United States each year, according to CDC estimates.  

"In order for us to support the highest level of patient care at our children's hospital, we require fast time to results, especially when it comes to dealing with infectious diseases," said Dr. Jennifer Dien Bard, Director, Clinical Microbiology and Virology Laboratory at the Children's Hospital Los Angeles. "Having tests that are easy to use and require only minimal hands-on time are key. The Luminex Group A Strep Assay has performed very well in our lab, and is a welcome addition to the ARIES® System test menu."

Dr. Ted E. Schutzbank, Technical Director, Specialized Testing and Microbiology at Ascension/St. John Providence added: "While the use of rapid antigen detection kits has been the standard of care in physicians' offices for years, the sensitivity of these tests has always been questionable, requiring follow-up testing of negative results, typically by bacterial culture. 

“Delaying treatment while awaiting lab results can lead to serious short-term sequelae such as scarlet fever, or long-term complications such as rheumatic fever. Replacement of rapid antigen testing by the ARIES® Group A Strep Assay will allow for a much faster definitive diagnosis of these infections and greatly enhanced patient care by ensuring timely administration of antibiotic therapy."

Overuse of antibiotics has caused the resistance of numerous species of bacteria, so accurate diagnosis is pivotal to mitigating unnecessary antibiotic use and guiding appropriate patient treatment. Molecular testing for respiratory pathogens has been shown to improve infection control efforts and reduce the use of unnecessary antibiotics, duration of treatment, length-of-stay, and hospital admissions.

"We are pleased to continue the rapid expansion of our infectious diseases portfolio with the FDA clearance of the ARIES® Group A Strep Assay," said Homi Shamir, President and Chief Executive Officer of Luminex. "Our broad respiratory offering provides both targeted assays, like the ARIES® Group A Strep Assay, and customizable disease state panels. With our breadth of respiratory testing options, clinicians have access to the testing flexibility necessary to quickly adapt to the varying clinical needs of their patients."

The ARIES® Group A Strep Assay, a real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test, is part of Luminex's comprehensive respiratory testing menu that also includes the ARIES® Bordetella Assay, ARIES® Flu A/B & RSV Assay, NxTAG® Respiratory Pathogen Panel, and VERIGENE® Respiratory Pathogens Flex Test.

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® is designed to run in multiple laboratory shifts and allows labs to simultaneously run both IVD assays and laboratory developed tests (LDTs) with MultiCode® Analyte Specific Reagents (ASR), when using a universal assay protocol.  All aspects of testing are automated, from sample preparation through analysis, providing answers in less than two hours with minimal hands-on.

Luminex offers a broad menu of Analyte Specific Reagents (ASR) based on our unique, patented MultiCode®-RTx Technology for the identification and quantification of various pathogens. Approximately 20 MultiCode ASRs are available for clinically relevant bacterial, viral, fungal, and protozoan targets.



Source: Company Press Release