NEW YORK (GenomeWeb) – Luminex said today that the US Food and Drug Administration has granted 510(k) clearance for its 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.
The firm noted that it is the sixth assay that the FDA has cleared for use on its Aries systems in the last 24 months.
Luminex President and CEO Homi Shamir said in a statement that the firm's "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 real-time PCR test is part of a Luminex 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.
Fast and accurate diagnosis of Group A Streptococcus infections is critical to ensuring that appropriate antibiotic therapy is started promptly, Luminex said, adding that invasive cases of the infection leads to as many as 1,600 deaths in the US each year.