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UPDATE: Luminex Gains FDA Clearance for Gastro Test; Expects Clearance for Newborn Test in H2

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This article has been updated from a version posted Jan. 10 to reflect the fact that Luminex has gained clearance for its gastrointestinal panel.

Luminex this week said that the US Food and Drug Administration has cleared its xTAG Gastrointestinal Pathogen Panel for marketing in the US.

The clearance follows comments made last week at the JP Morgan Healthcare conference in San Francisco by CEO Patrick Balthrop, who told investors that the company expected clearance within a month.

Balthrop said that the test meets an "unmet customer need" and addresses a $150 million market.

Luminex received a CE-IVD mark for the qualitative molecular multiplex diarrhea test in 2011. The Austin, Texas-based company claims that xTAG GPP can detect hospital-acquired infections, and 15 total gastrointestinal pathogens in a single, five-hour assay (BAN 10/30/2012).

GPP is one of two tests that Luminex expects the FDA will clear in 2013. Balthrop said that the company also 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.

Both tests are based on Luminex's xTAG technology and the xMAP platform to detect multiple targets in a single sample. In the xTAG assay, PCR products are subjected to an allele-specific primer extension step. 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 firm's 100/200 and MagPix instruments, and the results are analyzed by data-analysis software.

The Neoplex assay relies on Luminex's NeoPlex System, a fully automated, walk-away sample-processing instrument that incorporates the BSD 300 Semi-Automated Punch System and CardScan reader.

In addition to GPP and Neoplex 4, Luminex sells several FDA-cleared, xTAG-based tests including one for cystic fibrosis screening, one for respiratory viral testing, and a CYP2D6 pharmacogenomics assay.

Since Jan. 1, Luminex has been selling its molecular diagnostics products directly rather than via distributors. Balthrop said during his presentation that the change has been planned for three years and that Luminex has expanded its sales force in preparation for changing to a direct sales model. According to Balthrop, customer reaction to the move has been "positive." About a quarter of Luminex's molecular diagnostics sales have been realized through its distribution deals, representing about 10 percent of total sales, he added.

During his presentation, Balthrop also commented on the company's diagnostics pipeline. Luminex is currently focused on developing what it refers to as Project Aries, a new multiplex platform that combines technologies it gained through its recent acquisitions of GenturaDx and EraGen. Specifically, Luminex aims to join Gentura's IDbox platform, which performs low-plex, real-time PCR tests on a single-use cassette, with EraGen's MultiCode chemistry. Bathrop said that Luminex intends to launch the Aries system, which will enable customers to develop their own tests on the platform, next year, though he would not comment on the system's assay menu.

In addition to these Project Aries-related tests, Balthrop said that Luminex has other xTAG-based diagnostics in development, and noted that some were in the area of pharmacogenomics, but didn't elaborate as the company prefers to have "first mover status" on the clinical assays it introduces to the market.

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