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Luminex Lands FDA Clearance for Aries System, Herpes Assay

NEW YORK (GenomeWeb) – Luminex today announced that it has received 510(k) clearance from the US Food and Drug Administration for its Aries System and Aries Herpes Simplex Virus (HSV) 1&2 Assay.

The real-time PCR-based sample-to-answer Aries system detects and amplifies nucleic acids. It uses cartridges, internal barcode scanning, and other features to minimize operator errors and has a built-in touchscreen computer to save benchtop space.

Luminex expects to launch the product in the next few weeks and formally introduce it next month at the Association for Molecular Pathology annual meeting in Austin, Texas.

"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," Luminex CEO Homi Shamir said in a statement.

He added that expanding the Aries test menu will be a key priority to increase adoption and drive revenue growth. Luminex is running clinical trials for Clostridium difficile and Group B Streptococcus assays and expects to launch more in 2015.

In July, Luminex submitted the Aries platform and HSV assay to the FDA for clearance. In August, it submitted a 510(k) application to the FDA for a NxTAG Respiratory Pathogen panel.