PARC Team Purchases Illumina Genotyping Solutions for Study of Pharmacogenomics of Cardiovascular Disease; Multi-Phase Study Aims to Identify Genetic Markers and Determine Effect of Specific Genotypes on Individual Response to Statins.

SAN DIEGO -- Illumina, Inc. (NASDAQ: ILMN) announced today that it has signed an agreement with Children's Hospital Oakland Research Institute (CHORI) to provide reagents and instrumentation for a groundbreaking study aimed at determining the impact of single nucleotide polymorphisms (SNPs) on individual response to statins, a widely used class of cholesterol-lowering drugs. The study is being carried out as part of the NIH-funded research program, Pharmacogenomics and Risk of Cardiovascular Disease (PARC). At the end of the current five-year grant period, PARC aims to have identified critical genetic determinants of response to statin therapy that could be used by health care providers to ensure the best cardiovascular outcome and the lowest risk of treatment for each patient.

The PARC research program is led by Principal Investigator Ronald Krauss, M.D, Senior Scientist and Director of Atherosclerosis Research, at CHORI. Genotyping will be directed by Co-Principal Investigator Deborah Nickerson, Ph.D., Professor of Genome Sciences at the University of Washington. Data analysis will be overseen by Co-Principal Investigator Jerome Rotter, M.D., Board of Governors' Chair in Medical Genetics and Director of Research, Medical Genetics Institute at Cedars-Sinai Medical Center in Los Angeles. Other investigators with key roles in PARC include Mark Rieder, Ph.D. of the University of Washington, Paul Ridker, M.D. and Dan Chasman, Ph.D. of Brigham and Women's Hospital and Harvard Medical School, Paul Williams, Ph.D. of Lawrence Berkeley National Laboratory, and Russell Wilke, M.D. of Marshfield Clinic. As a team, the PARC investigators have expertise in every aspect of the project, including genomics, statistical genetics and informatics, clinical pharmacology and cardiology, laboratory measurements of cardiovascular risk factors, and epidemiology.

The experimental plan divides the study into four sequential phases to ensure adequate statistical power and minimize the risk of false positive results in identifying the most informative SNPs associated with statin response and clinical cardiac endpoints. Statin response phenotypes to be evaluated include levels of LDL and HDL (low- and high-density lipoproteins) and their subfractions, indices of cholesterol synthesis and absorption, and inflammatory markers. The study also aims to identify SNPs associated with statin-related myopathy, an uncommon side effect characterized by damaged muscles.

Sample genotyping for all phases will be performed in Dr. Nickerson's laboratory with a new, fully automated Illumina BeadStation system and four leased Illumina BeadArray Readers to accommodate the sample throughput planned in the project schedule. Samples will be drawn from large clinical trials previously carried out by investigators in PARC and other research programs that have tested effects of the statin drugs simvastatin, pravastatin, rosuvastatin and atorvastatin on laboratory and clinical measures of cardiovascular disease risk.

Phase I will involve whole-genome association analysis of over one thousand clinical samples using the Sentrix(R) Human-1 BeadChip and a follow-on Sentrix HumanHap-1 BeadChip that can query over 250,000 TagSNPs (see note) derived from the International HapMap Project. The study will use Illumina's powerful Infinium(TM) assay, which enables the intelligent selection and analysis of virtually any SNP in the genome, providing coverage and multiplex levels that are limited only by the number of features on the BeadChip. Infinium performance, as measured by call rate, accuracy and reproducibility, is comparable to Illumina's GoldenGate(R) assay protocol, the gold standard of the HapMap Project.

Following confirmatory analysis of Phase I findings on additional clinical samples and cohorts, subsequent phases will systematically evaluate haplotype blocks, specific haplotypes within each block, and SNPs within those haplotypes to identify the most informative variants and those that have causal association with clinical phenotypes. Over 10,000 samples will be tested in the latter phases of the project, which will employ fine mapping techniques using Illumina's GoldenGate assay protocol, custom panels of SNP markers, and Sentrix Universal Array Matrices.

Commenting on the study, Dr. Krauss stated "This project will be among the very first to fully leverage HapMap data to streamline genome-wide analysis. The new genotyping tools will enable the PARC team to economically conduct large-scale, multicohort-designed experiments and deliver results of meaningful value to the clinic. We look forward to working with Illumina on this project, the design of which we believe will serve as a model for studying the pharmacogenomics of a wide range of diseases."

According to Jay Flatley, Illumina President and CEO, "We're tremendously excited to work with the PARC investigators and delighted that our genotyping solutions will contribute to this seminal study. This is the kind of research that will demonstrate the benefits of pharmacogenomics and fuel the evolution toward personalized medicine."

About PARC

For more information on PARC objectives and team members, visit (http://www.pharmgkb.org/network/members/parc.jsp). PARC is funded by the National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov/index.htm ) and is a component of NIH's Pharmacogenetic Research Network, a nationwide group of scientific programs studying the effects of genes on people's responses to a wide variety of medicines. This Network is coordinated by the National Institute of General Medical Sciences (http://www.nigms.nih.gov/pharmacogenetics/ ) . The PARC findings will be posted to and made publicly available on PharmGKB (http://www.pharmgkb.org/network/members/pharmgkb.jsp), an integrated knowledge database for the provision of data and resources for pharmacogenetic research.

About Children's Hospital & Research Center at Oakland

Children's Hospital & Research Center at Oakland (http://www.childrenshospitaloakland.org) is a designated Level I pediatric trauma center and the largest pediatric critical care facility in the region. The hospital has 170 licensed beds and 166 hospital-based physicians in 30 specialties, two thousand employees, and an operating budget of $200 million. With more than 300 basic and clinic investigators and an annual budget of over $43 million, Children's Hospital Oakland Research Institute, has made significant progress in areas including pediatric obesity, cancers, sickle cell disease, AIDS/HIV, hemophilia and cystic fibrosis.

About Illumina

Illumina (www.illumina.com) develops and markets next-generation tools for the large-scale analysis of genetic variation and function. The Company's proprietary BeadArray technology -- now used in leading genomics centers around the world -- provides the throughput, cost effectiveness and flexibility necessary to enable researchers in the life sciences and pharmaceutical industries to perform the billions of tests necessary to extract medically valuable information from advances in genomics and proteomics. This information will help pave the way to personalized medicine by correlating genetic variation and gene function with particular disease states, enhancing drug discovery, allowing diseases to be detected earlier and more specifically, and permitting better choices of drugs for individual patients.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: this release may contain forward-looking statements that involve risks and uncertainties. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are the costs and outcome of Illumina's litigation with Affymetrix, the Company's ability to scale and integrate CyVera technology, the ability to further scale oligo synthesis output and technology to satisfy market demand deriving from the Company's collaboration with Invitrogen, Illumina's ability to further develop and commercialize its BeadArray technologies and to deploy new gene expression and genotyping products and applications for its platform technology, to manufacture robust Sentrix(R) arrays and Oligator(R) oligonucleotides, and other factors detailed in the Company's filings with the Securities and Exchange Commission including its 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. Illumina disclaims any intent or obligation to update these forward-looking statements beyond the date of this release.

Note about Haplotype TagSNPs

Sets of SNPs on the same chromosome are inherited in blocks; haplotypes are patterns of SNPs within a block. Haplotype blocks may contain large numbers of SNPs, but often just a few of them - called TagSNPs - are sufficient to uniquely identify a specific haplotype. Because TagSNPs serve as proxies for specific haplotypes, scientists can analyze genome-wide variation very comprehensively and efficiently by examining between 250,000 and 500,000 TagSNPs instead of the entire 10 million SNP population. This streamlines the research process and opens doors to disease association studies that can get answers better, faster and cheaper than ever before.

Illumina is a Principal Investigator in the HapMap Project and has also supplied its genotyping systems, arrays and reagent to other HapMap investigators in Canada, China, England, Japan and the United States. Well over 500,000 GoldenGate assays have now been developed and validated for the HapMap Project.