Luminex Receives FDA Clearance
News Oct 08, 2015
Luminex Corporation has announced that it has received FDA clearance for the company's ARIES® System and ARIES® HSV 1&2 Assay.
ARIES® is a sample to answer system 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.
Two independent modules each support from one to six cassettes, allowing for both STAT and Batch testing IVD and MultiCode® Analyte Specific Reagents can be run simultaneously with a common Universal Assay Protocol. An integrated touchscreen PC eliminates the need for a separate computer, stand-alone keyboard, and mouse; thus maximizing valuable bench space.
The company anticipates market launch in the next few weeks and a formal introduction at the Association for Molecular Pathology annual meeting in Austin, Texas, November 4-7, 2015.
"We are pleased to have received a rapid clearance from the FDA for our game-changing ARIES® System and ARIES® HSV 1 & 2 Assay as it represents a significant milestone for Luminex and a turning point for the molecular diagnostic industry," said Homi Shamir, President and CEO of Luminex. "There has never been more pressure on clinical laboratories to increase efficiency while improving the overall quality of patient care through the delivery of accurate and timely data. To solve this challenge, Luminex designed the ARIES sample to answer testing platform to streamline the workflow and raise the performance bar for all laboratory professionals no matter how big or small the setting. To increase ARIES®' utilization and drive rapid top-line revenue growth a key priority will be to rapidly expand our test menu to cover the full range of disease modules. We believe that the launch of ARIES® will increase our potential market to cover 6,500 hospital labs, a 13 fold increase over our current available customer base in the US."