A latest-generation molecular diagnostics platform, due for release to the clinical laboratory market in the near future, has already been cleared for use by the [US] Food and Drug Administration (FDA).

The Luminex Corporation (Austin, TX, USA) has announced that the receipt of FDA clearance for the company's new ARIES System and its dedicated ARIES HSV (herpes simplex virus) 1&2 Assay.

The herpes simplex virus 1 (HSV-1) causes a lifelong, contagious infection, which is common and endemic throughout the world. It is mainly transmitted through oral-oral contact and causes "cold sores." There is no cure, although treatment can reduce symptoms. HSV-2 infection, which causes genital herpes that is characterized by the occasional appearance of painful genital ulcers, is widespread and mainly sexually transmitted. It is estimated that up to 20 million people are newly infected with HSV-2 each year.

The ARIES system utilizes the Luminex proprietary MultiCode real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies. MultiCode products, which are used for the early detection of infectious diseases and genetic-based conditions, are centered on the unique MultiCode bases, isoC and isoG. The synthetic isoC:isoG DNA base pair differs from the naturally occurring base pair in its hydrogen bonding pattern. As a result, the MultiCode bases, isoC and isoG, can only base pair with each other. This property enables site-specific incorporation of the isobases during amplification. The isoC and isoG MultiCode bases form the building blocks for Luminex’s next generation MultiCode assays for nucleic acid-based testing.

The ARIES instrument 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. An integrated touchscreen PC eliminates the need for a separate computer, stand-alone keyboard, and mouse; thus maximizing valuable bench space.

"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 USA."

Luminex plans to introduce the ARIES products at the November 4-7, 2015, Association for Molecular Pathology annual meeting in Austin (TX, USA).

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