Illumina, Inc. (NASDAQ:ILMN) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for the company's BeadXpress system for multiplex genetic analysis. According to the FDA's indications of use, the BeadXpress system - consisting of Illumina's BeadXpress Reader and VeraScan software - is an in-vitro diagnostic device intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology.
“This clearance is a significant step forward in progressing our partnership in the clinical marketplace”
"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," said Jay Flatley, president and CEO. "It demonstrates Illumina's ability to meet stringent regulatory requirements in designing and manufacturing an FDA-cleared in-vitro diagnostic device. This will serve as an important foundation for our future plans in the diagnostics area. 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."
Illumina introduced the BeadXpress system in 2007 with Research Use Only kits for custom genotyping, gene expression, methylation and protein analysis. Since then it has been adopted by research, agricultural, industrial and pharmaceutical institutions worldwide. Utilizing uniquely inscribed digital microbeads, VeraCode technology provides high-quality data, broad multiplexing capability and assay flexibility. Illumina submitted the system for FDA review in September 2009.
"510(k) clearance opens up a wide range of new possibilities for our many clinical research and commercial partners, who can now pursue diagnostic development on our proven, high-performance BeadXpress platform," said Gregory Heath, Ph.D., senior vice president and general manager, Diagnostics. One of those partners is EraGen Biosciences, Inc., which concluded a licensing agreement with Illumina in 2009 to transfer their assays onto the BeadXpress System. "This clearance is a significant step forward in progressing our partnership in the clinical marketplace," said Irene Hrusovsky, M.D., president and CEO of EraGen Biosciences.
Illumina launches its first product enabling long- and short-read sequencing on one instrument