Luminex Corp, Austin, Tex, has received FDA premarket notification (510(k)) clearance for its Aries molecular diagnostics system and proprietary assay for herpes simplex virus (HSV) 1 and 2.
Aries is a sample-to-answer system designed to increase laboratory efficiency, ensure result accuracy, and fit into today’s Lean laboratory environment. The system uses internal barcode scanning to minimize operator errors. Two independent modules each support from one to six cassettes. As a result, the system can run stat and batch testing in vitro diagnostic and MultiCode analyte-specific reagents simultaneously, using a common universal assay protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, thus maximizing bench space.
The company anticipates market launch in the next few weeks and a formal introduction at the annual meeting of the Association for Molecular Pathology in Austin, Tex, November 4–7, 2015.
“We are pleased to have received a rapid clearance from FDA for our game-changing Aries system and Aries HSV 1 and 2 assay, as it represents a significant milestone for Luminex and a turning point for the molecular diagnostics industry,” says Homi Shamir, president and chief executive 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,” Shamir adds. “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.”
For more information, visit Luminex.