Luminex Corporation Receives FDA Clearance
News Aug 04, 2016
Luminex Corporation has announced that it has received FDA clearance for the ARIES® Flu A/B & RSV Assay. This is the second assay the FDA has cleared for use on the Luminex ARIES® System. The ARIES(R) Flu A/B & RSV Assay is a rapid, accurate method for the detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) from nasopharyngeal swab (NPS) specimens using the ARIES(R) System.
The ARIES® Flu A/B & RSV Assay delivers results in less than 2 hours for the detection and differentiation of three key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) using a sample to answer platform. This new assay also allows for panel customization with the unique ability to only report the results of interest.
"Clinical labs everywhere are trying to accomplish more with less these days, so we need each instrument to perform more tasks," said Dr. Stefan Juretschko, Director, Infectious Diseases Diagnostics, Northwell Health. "The ARIES® platform lets us run samples as they come in and turn results around quickly. With FDA-cleared assays as well as the ability to run lab-developed tests, it offers us unmatched flexibility."
"In the battles clinicians wage to fight infectious disease, accurate and quickly actionable diagnostic test results are critical for success. The ARIES® Flu A/B & RSV Assay requires very limited hands-on time that accelerates the time to result and provides for increased accuracy," said Nachum "Homi" Shamir, President and CEO of Luminex Corporation. "We are proud to have received our second FDA clearance for an ARIES® assay, are delighted that these new clinical tests are being embraced by our customers, and look forward to further expansion of our ARIES® menu."
A simple blood test reliably detects signs of brain damage in people on the path to developing Alzheimer’s disease – even before they show signs of confusion and memory loss, according to a new study from Washington University School of Medicine in St. Louis and the German Center for Neurodegenerative Diseases in Germany.READ MORE