NEW YORK (GenomeWeb) – Luminex announced today that it has received clearance from the US Food and Drug Administration for its Influenza A/B and Respiratory Syncytial Virus PCR-based assays on the Aries platform.
The company, which received FDA 501(k) clearance for the both the Aries platform and the Aries Herpes Simplex Virus (HSV) 1&2 Assay in October 2015, said the Flu A/B & RSV Assay can detect and differentiate between influenza A virus, influenza B virus, and RSV in less than two hours. The assay also allows for panel customization and is enabled to report only results of interest.
"In the battles clinicians wage to fight infectious disease, accurate and quickly actionable diagnostic test results are critical for success," said Luminex CEO Homi Shamir in a statement. "The Aries Flu A/B & RSV Assay requires very limited hands-on time that accelerates the time to result and provides for increased accuracy."
In June, Luminex received CE-IVD marking for the Flu A/B & RSV Assay, and received FDA clearance as well as CE-IVD marking for its Aries M1 in vitro diagnostic system — a lower-throughout version of the company's Aries System — last month.