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Luminex to Target Smaller Clinical Labs with FDA-Cleared MagPix System, Gastro Pathogen Panel

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The US Food and Drug Administration has cleared Luminex's xTAG Gastrointestinal Pathogen Panel for use on the firm's benchtop MagPix instrument.

Luminex CEO Patrick Balthrop told BioArray News that the GPP is the "first clinical assay" to be cleared on the compact system, which is gaining a "larger percentage" of the company's installed base of instruments, and that MagPix's clearance will offer the firm access to potential clients who lack the bench space to accommodate its older, larger systems.

Luminex claims the GPP can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample. The firm already gained clearance for the assay in January for use on its Luminex 200 instrument (BAN 1/15/2013.

Launched in 2005, the Luminex 200 is capable of multiplexing up to 100 analytes in a single well of a microtiter plate. The Austin, Texas-based company already sells several FDA-cleared, xTAG-based tests for use on the 200, including one for cystic fibrosis screening, one for respiratory viral testing, and a CYP2D6 pharmacogenomics assay, in addition to the GPP.

The more compact MagPix, in comparison, was launched less than three years ago. Luminex claims the multiplexing platform is capable of performing qualitative and quantitative analysis of proteins and nucleic acids in a variety of sample matrices, and that the system can perform up to 50 tests in a single reaction volume.

The company also offers a third platform called FlexMap3D that relies on differentially dyed fluorescent microsphere sets to allow multiplexing of up to 500 assays within a single sample.

Balthrop said that Luminex has shipped 10,000 instruments to date across these three platforms, but noted that the MagPix continues to rise in popularity. Specifically, he said that Luminex sold 420 MagPix systems in 2012, roughly double the amount it shipped in 2011, its first full year of availability.

Balthrop said that the company is pleased with this increased traction and its strategic implications as it will allow clinical laboratories of all sizes to offer xTAG GPP on the benchtop instrument, Balthrop said.

Luminex is betting on the GPP to expand its presence in the clinical market. In January, Balthrop said that the GPP meets an "unmet customer need" and addresses a $150 million market (BAN 1/15/2013.

The assay is based on the firm's xTAG technology, where PCR products are subjected to an allele-specific primer extension step and the 5' end of the primers is then attached to an xTAG universal tag sequence that is hybridized to the complementary anti-tag sequence coupled to a particular xMAP bead array. The hybridized beads are subsequently read on the Luminex 100/200 or MagPix, and the results are analyzed by data-analysis software.

The GPP is one of two tests that Luminex expects the FDA will clear in 2013. Balthrop has said that the firm anticipates its xMAP NeoPlex 4 assay to be available for clinical use by the second half of the year.

NeoPlex 4 can be used to test newborns for analytes that can be indicators of congenital hypothyroidism, congenital adrenal hyperplasia, and cystic fibrosis. However, instead of being available for use on its 200 or MagPix platforms, Luminex's NeoPlex assay is run on Luminex's NeoPlex System, an automated sample-processing instrument that incorporates its BSD 300 Semi-Automated Punch System and CardScan reader.

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