Illumina, Inc. Receives FDA 510(k) Clearance for VeraCode(R) Genotyping Test for Factor V (Leiden) and Factor II (Prothrombin)

SAN DIEGO--(BUSINESS WIRE)--Illumina, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for the VeraCode® Genotyping Test for Factor V (Leiden) and Factor II (Prothrombin). The VeraCode Genotyping Test is comprised of the company’s VeraCode digital microbead technology and proprietary assay chemistry. The BeadXpress® System, which received a separate 510(k) market clearance, is FDA-cleared for in vitro diagnostic use only with the VeraCode Genotyping Test for Factor V and Factor II.

About Illumina

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.

Contact:

Illumina, Inc. Investors: Peter J. Fromen Sr. Director, Investor Relations 858-202-4507 pfromen@illumina.com or Media: Wilson Grabill Public Relations 858-882-6822 wgrabill@illumina.com