Illumina said this week that the US Food and Drug Administration recently granted 510(k) clearance for the firm's BeadXpress system for multiplex genetic analysis. Illumina submitted the holographic microbead-based system, which includes its BeadXpress Reader and VeraScan software, with an undisclosed genetic test to the FDA for review in September 2009.
CEO Jay Flatley called the clearance of BeadXpress for use in in vitro diagnostics a "significant and exciting transitional step" for the company into the diagnostics market.
"Ultimately, our 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," Flatley said.
Though Illumina has to date sold products for research use, the company has long been planning a move into the diagnostics arena, and last year opened a Clinical Laboratory Improvement Acts-compliant lab at its San Diego campus. 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).
Part of Illumina's diagnostics strategy is to offer tests through its CLIA lab, and to enable partners to design and offer laboratory-developed tests in their own facilities. Madison, Wis.-based EraGen Biosciences, for example, last year concluded a licensing agreement with Illumina to transfer its assays onto the BeadXpress System.
Gregory Heath, senior vice president and general manager of diagnostics at Illumina, said in a statement that the clearance "opens up a wide range of new possibilities for our many clinical research and commercial partners, who can now pursue diagnostic development" on the BeadXpress.
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 last week, company officials said the system has been selling well.
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 has other continuing diagnostic programs, including one each on gastric and ovarian cancers. The company 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).
During the R&D event, Heath also discussed Illumina's plan to have its array platform cleared by the FDA. Illumina's submission to the agency includes the iScan, plus the HumanCytoSNP-12 chip and HumanOmni1-Quad. Heath said at the time that Illumina planned to "start the discussion with the FDA about intended use, structure of clinical trials, and get some guidance from them about how we are going to approach this."