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National Cancer Institute Purchases Production-Scale BeadLab From Illumina For Array-Based Genetic Analysis

Posted on: Thursday, 1 September 2005, 06:00 CDT

Flexible Technology Platform to Enable Broad Range of Whole-Genome and Focused Genotyping Studies for Breast and Prostate Cancers

Illumina, Inc. (NASDAQ:ILMN) today announced an agreement with the National Cancer Institute (NCI) for the purchase and installation of an Illumina(R) BeadLab at the Institute's Advanced Technology Center Core Genotyping Facility in Gaithersburg, Maryland. The BeadLab, a production-scale genetic analysis laboratory, will be used initially for research into the genetics of breast and prostate cancer and directly support the Cancer Genetic Markers of Susceptibility (CGEMS), an NCI Strategic Initiative coordinated through the NCI's Division of Cancer Epidemiology and Genetics (DCEG) and the office of Cancer Genomics (OCG).

Under the guidance of Stephen J. Chanock, M.D., an NCI Senior Principal Investigator, the Institute will leverage the BeadLab and related SNP (single nucleotide polymorphism) genotyping solutions from Illumina for multi-phase projects designed to identify and validate cancer biomarkers, and then incorporate those biomarkers into a highly multiplexed SNP genotyping panel with predictive and pharmacogenomic value. The BeadLab purchase and planned studies derive from earlier and ongoing work performed for the NCI's SNP500 Cancer Project at Illumina's genotyping service facility.

The BeadLab is an end-to-end genetic analysis solution built around Illumina's proprietary BeadArray(TM) technology and featuring extensive automation, parallel sample throughput, high-multiplex assay protocols, sample tracking, allele-calling software, low running cost per sample and industry-leading performance. Depending on the array platform being used, the BeadLab will be able to process between 500 and over 1000 samples per day. The BeadLab will also support gene expression profiling of large sample sets and new methods such as Illumina's DASL(TM) assay for profiling of degraded RNAs from formalin-fixed, paraffin-embedded (FFPE) samples.

NCI plans to use the BeadLab to help achieve the experimental scale, analytical performance, and per-sample price points needed to deepen understanding of the role of SNPs in breast and prostate cancer. The Institute hopes that project design and results will serve as a model and help guide subsequent studies into other cancers with well-defined epidemiological endpoints.

Included in the experimental scope is the development of two focused genotyping panels. The first will use Illumina's new Infinium(TM) assay and multi-sample Sentrix(R) BeadChip to genotype approximately 15,000 loci for each of over 6,000 DNA samples. A follow-on phase will involve development of a high-value pool of multiplexed SNPs offering statistical association with prostate cancer. The pool will contain 1536 assays that will be processed using Illumina's GoldenGate(R) genotyping protocol, then hybridized and imaged on the Sentrix Array Matrix, a microplate-compatible array format that enables analysis of 96 multiplexed samples at the same time. The NCI expects to genotype over 15,000 samples with the GoldenGate panel, defining in the process a validated set of biomarkers for prostate cancer and enabling development of molecular diagnostic tools for use in the clinic.

"Dr. Chanock and his research colleagues both inside and outside the National Cancer Institute are laying crucial groundwork for understanding a broad range of cancers," stated Jay Flatley, Illumina President and CEO. "We're very pleased to be able to contribute to these studies, and we share the NCI's vision of enabling earlier and more effective cancer intervention and ultimately, improving clinical outcomes."

About the NCI

The National Cancer Institute (www.cancer.gov) is a component of the National Institutes of Health (NIH) within the Department of Health and Human Services and is the Federal government's principal agency for conducting and supporting research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention and treatment of cancer. The NCI plays a key role on a number of NIH Roadmap activities including the Epidemiology and Genetics Research Program (EGRP), which brings to bear the expertise of scientists to increase our understanding of cancer etiology and prevention. A major trend in modern epidemiologic research is the integration of molecular/mechanistic approaches from the basic sciences with more standard population-based approaches to estimating associations between potential risk factors and cancer incidence.

About Illumina

Illumina (www.illumina.com) is developing 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.

Source: Business Wire

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