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Luminex Provides Update on Next-Generation nxTAG Multiplexing Platform Development

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NEW YORK (GenomeWeb) – Luminex last week provided an update on nxTAG, its next-generation multiplexing technology in development, pledging a "seamless upgrade" for existing customers of its xTAG bead array products, and promising to have nxTAG in customers' hands by sometime next year.

CEO Patrick Balthrop discussed the new technology during a presentation at the UBS Global Healthcare Conference in New York. While the majority of Balthrop's webcast remarks related to Aries, the sample-to-answer, real-time PCR-based system that the Austin, Texas-based firm is in the midst of of introducing in Europe ahead of a US launch, he also addressed nxTAG, which Luminex sees as an improvement of the company's xTAG chemistry that underpins much of its current molecular diagnostics menu, including its US Food and Drug Administration-cleared xTAG Respiratory Viral Panel and Gastrointestinal Pathogen Panel.

"The goal of this new chemistry is to provide customers with a sample-to-answer solution and simplified workflow that significantly reduces hands-on time," said Balthrop. "For those high-volume labs that are current customers of our multiplexing products this new technology will provide elegant results in a streamlined format," he said.

Luminex first discussed nxTAG late last year. The approach is based on its existing xTAG chemistry, which consists of several steps. First, multiplexed PCR is performed to amplify regions of interest in target genes. Next, the reaction is treated to remove excess nucleotides and primers, followed by a primer extension step that is specific for the allele or the infectious agent that is being analyzed. The 5' end of the primers is attached to an xTAG universal tag sequence and the 5' universal tag sequence is then hybridized to the complementary anti-tag sequence coupled to a particular xMAP bead set, prior to read out and analysis.

As previously reported by Luminex, nxTAG incorporates the primers, enzymes, and fluorescent reporters all into a single mix in the wells of a sealed 96-well plate, meaning that the firm's customers using the new technology will only need to pipette their nucleic acid samples into the plate's wells, re-seal it, and run it in a thermal cycler. When the PCR program is complete, the plate is transferred to the company's benchtop MagPix instrument to be read out.

At the time when Luminex first introduced the technology, it said that the assay's hand-on time would be reduced from about two hours to a few minutes, and that the risk of contamination would be eliminated, as the plate is never unsealed after the samples are added.

The first new product to become available that relies on the nxTAG technology will be an updated version of the company's xTAG RVP that will also include new content. Balthrop said at UBS that the firm is on track to achieve FDA clearance and a CE-IVD marking for the test in 2015. Customers who own one of Luminex's 10,000 installed bead array systems will also be able to adopt the nxTAG technology, rather than have to invest in new instrumentation, Balthrop said.

"We anticipate a seamless upgrade for customers," said Balthrop. "Since nxTAG is an improvement to our current chemistry, it will run on our current installed base of systems, providing an easy transition for customers," said Balthrop. "We also intend to move this product down market over time to take extensive advantage of that installed base and regain and expand share during that period," he said. "We continue to make progress on this strategic program and we expect to have a product for evaluation in customers hands in the very near future," Balthrop added, without elaborating.

While Luminex's R&D team continues to work on nxTAG, the company is also looking to integrate its multiplexing technology with its RT-PCR-based Aries platform. Balthrop noted at UBS that the company is developing an expanded platform called Aries v2 that will integrate its core technologies.

"Combining our RT-PCR capabilities with high multiplexed assays is something that has never been done before in our industry," he said. He noted that Luminex has designed its current generation Aries system to accommodate an upgrade to the future system that combines RT-PCR and multiplexing, and that customers should expect an easy and economical launch for Aries v2 when it becomes available in two years.

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