Illumina Receives FDA 510(k) Clearance for Its BeadXpress® Multiplex Analysis System
Provides Clinically Validated Platform for the Next Generation of Molecular Diagnostic Tests
SAN DIEGO--(BUSINESS WIRE)--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.
"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"
."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.
For more information, please visit http://www.illumina.com.
Illumina (http://www.illumina.com) is the leading developer, manufacturer, and marketer of integrated systems for the analysis of genetic variation and biological function. Using our proprietary technologies, we provide a comprehensive line of products and services that currently serve the sequencing, genotyping, and gene expression markets, and we expect to enter the market for molecular diagnostics. Our customers include leading genomic research centers, pharmaceutical companies, academic institutions, clinical research organizations, and biotechnology companies. Our tools provide researchers around the world with the performance, throughput, cost effectiveness, and flexibility necessary to perform the billions of genetic tests needed to extract valuable medical information from advances in genomics and proteomics. We believe this information will enable researchers to correlate genetic variation and biological function, which will enhance drug discovery and clinical research, allow diseases to be detected earlier, and permit better choices of drugs for individual patients.
This release contains forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those in any forward-looking statements include challenges inherent in new product development and manufacturing and the other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update any forward-looking statements after the date of this release.