NEW YORK (GenomeWeb News) – Illumina today announced that the US Food and Drug Administration has granted 510(k) clearance for the firm's BeadXpress multiplex system.
The FDA cleared the system, which includes the BeadXpress Reader and VeraScan software, for in vitro diagnostic applications. Illumina said that it can simultaneously detect multiple analytes in a DNA sample using the firm's VeraCode holographic microbead technology.
"This approval represents a significant and exciting transitional step for Illumina into the diagnostics field, where the potential is great for molecular medicine to make a real difference in the way disease is detected and ultimately prevented and treated," Illumina President and CEO Jay Flatley said in a statement. "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."
The BeadXpress system was launched in 2007 with Research Use Only kits for custom genotyping, gene expression, methylation, and protein analysis. It is based on technology that Illumina gained through its 2005 acquisition of Cyvera.
An Illumina official recently said that the firm also plans to submit its iScan system and accompanying arrays and software to the FDA for clearance, according to GenomeWeb Daily News sister publication BioArray News.
"We will be migrating the iScan system into the clinical space and we will bring this through the FDA," Greg Heath, Illumina's senior VP and GM of diagnostics, said during Illumina's annual R&D day for analysts, which was webcast in January. "The first area we want to attack is in the space of cytogenetics. We decided to submit a pre-IDE to the FDA to start the dialogue about using our cyto arrays for this clinical indication."
The expansion of Illumina's technologies into the molecular diagnostics space opens up a large market opportunity for the firm. According to life sciences consulting firm Scientia Advisors, the worldwide molecular diagnostics market was around $3.8 billion in 2008 and is growing at a rate of 15 percent annually.