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Illumina Hopes to Target $3B Molecular Dx Space with BeadXpress Tests

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By Justin Petrone

What was once a "market for the future" is "starting to happen" for Illumina, according to Chief Financial Officer Christian Henry.

Henry told investors last week at the Robert W. Baird Growth Stock Conference in Chicago that the San Diego-based life-science tools vendor is now moving its holographic digital microbead-based BeadXpress system from the research market, where he said it addresses a $650 million market in fine mapping, clinical validation, and screening, into the much larger molecular diagnostics market, which he said is a "$3 billion opportunity" for Illumina.

Henry's remarks coincided with the US Food and Drug Administration's clearance of two panels that run on the BeadXpress system. The company received 510(k) clearance for its VeraCode Genotyping Test for Factor V mutation (Leiden) and Factor II mutation (prothrombin), the most common genetic defects for inherited thrombosis. The clearance came weeks after the FDA cleared the BeadXpress system and an undisclosed assay for clinical use (BAN 5/4/2010).

The clearances allow Illumina to get to a "whole new class of customers with an FDA-approved instrument," Henry said. Moreover, it gives the company a platform to attack rivals in the molecular diagnostics space, such as Austin, Texas-based Luminex.

Luminex's xMAP liquid bead array platform is used by a number of firms for numerous applications, from allergy testing to cystic fibrosis carrier detection, to human leukocyte antigen testing.

Affymetrix, Illumina's competitor in the microarray market, has a digitally encoded microparticle technology in development that it calls liquid arrays for use in low- to mid-plex assays. The company recently said the platform is in product development (BAN 5/11/2010). That technology could also compete against BeadXpress in the future.

"Our strategy is to build an installed base with the BeadXpress system," said Henry. He said BeadXpress has "unique characteristics" that make it "very competitive" against Luminex. "They have a very successful business, and we have a product that is approved that can go up against them," he said. He did not elaborate.

In the past, Illumina has positioned the system, which enables users to assay between one and several hundred markers, for screening and validation. According to the company, BeadXpress can currently support custom low- to mid-plex genotyping, custom low- to mid-plex methylation analysis, SNP screening, and protein screening.

Illumina's strategy for the BeadXpress relies not only on selling FDA-cleared kits, but also working with partners that can adopt internally developed tests for use on the platform. Henry noted that Madison, Wis.-based EraGen Biosciences is converting its RT_PCR-based assays for use on the BeadXpress.

EraGen announced a strategic partnership with Illumina in November 2009, and last week said it received FDA clearance for a PCR-based herpes simplex virus test than assays vaginal lesions collected via a swab.

Another route for Illumina to the diagnostics market is via its US Clinical Laboratory Improvement Amendments-compliant lab. Henry said that the CLIA lab is being used primarily for human whole-genome sequencing, but that in the future, Illumina has the ability to make diagnostic content available on the BeadXpress through the lab.

A third pillar of Illumina's diagnostics strategy is to develop its own tests on the BeadXpress system. Henry said that Illumina has already completed the sequencing of 25 tumor-normal pairs and is assessing the results as part of this biomarker discovery program. Illumina has "uncovered some interesting things," but it will "take time" to determine how to apply those discoveries, he said. Illumina also has an ongoing discovery program in gastric cancer, and later this year will begin a colorectal cancer project, Henry said.

Illumina announced earlier this month that it received clearance for the BeadXpress system, which includes its BeadXpress Reader and VeraScan software. CEO Jay Flatley said at the time that the firm's ultimate goal is to "become a leader in translational medicine, focusing on complex diseases that benefit from high-performance analysis, including genotyping, copy number, gene expression, methylation, and protein analysis."

The company has separately submitted its iScan array reader and a cytogenetics package to the FDA to begin the process of obtaining clearance for its microarrays (BAN 1/26/2010).

Illumina acquired the technology platform that serves as the basis for BeadXpress when it bought CyVera in 2004. In 2007, BeadXpress was rolled out with an RUO label for custom genotyping, gene expression, methylation, and protein analysis.

During Illumina's first-quarter earnings call earlier this month, company officials said the system has been selling well for research use. Flatley said there had been "strong demand" for the BeadXpress during Q1, which led to sequential and year-over-year growth in orders and shipments for the system's VeraCode reagents. Illumina last month introduced its VeraCode ADME Core Panel, which is designed to help researchers understand the genetic variability associated with drug response and predisposition (BAN 4/13/2010).

In addition to the ADME panel, Heath said earlier this year during Illumina's annual R&D Day event with analysts that the firm has been offering a research-use-only 185-marker pharmacogenomics panel for drug metabolism to some pharmaceutical partners, who use it in their drug-development programs. Out of the 185 markers in the assay, he said there is "huge potential" to eventually bring each one through the FDA's 510(k) approval process.

Heath also said at the time that Illumina is also developing a multi-drug-resistance panel, a herpes panel, and a respiratory viral panel, all of which will likely be deployed on the BeadXpress (BAN 1/26/2010).

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