Breakthrough Turnaround Time for Human Genome Sequencing Available via Illumina’s CLIA-Certified Laboratory

SAN DIEGO--(BUSINESS WIRE)--Sep. 11, 2012-- Illumina, Inc. (NASDAQ:ILMN) today announced the introduction of its rapid Individual Genome Sequencing (IGS) service with a turnaround time in as little as two weeks. Rapid turnaround whole genome sequencing services were announced by Illumina in June 2012, enabled by technology innovations to the HiSeq® platform. Now these advancements have been implemented in Illumina’s CLIA-certified laboratory to enable the same fast turnaround for the IGS service.

The IGS service is only available through a physician’s order and is designed to assist clinicians with diagnosis and treatment decisions. As the only CLIA-certified, CAP-accredited whole genome sequencing service laboratory in the world, Illumina continues to increase access and lay the foundation for routine clinical use of whole-genome sequencing.

“Illumina has long believed that sequencing will become a mainstream practice in the clinical setting. By delivering a whole human genome in as little as two weeks, we have taken significant strides towards that goal,” said Illumina President and CEO Jay Flatley. “Whole genome sequencing is quickly gaining recognition for its potential in diagnostics and treatment decisions, particularly in cases where physicians are challenged with identifying a disorder based on symptoms that don't quite fit with a known disease. When this happens, rapid whole-genome sequencing can provide big-picture information about genetic makeup, enabling physicians to make more informed decisions and patients to obtain answers more quickly.”

Validated for laboratory use in accordance with CLIA and CAP regulations and guidelines, Illumina’s fast IGS service uses Illumina’s HiSeq 2500® sequencing system, which is capable of completing a sequencing run on a whole human genome in one day. The service will continue to deliver the highest quality, most comprehensive data with the broadest coverage of exomic, promoter, and regulatory regions, as well as fully annotated variants to facilitate clinical interpretation, now available faster. Illumina is also working on a suite of analytic tools and professional services in collaboration with physicians and medical geneticists to improve clinical interpretation.

“Illumina has delivered on the promise of personalized healthcare by not only enabling clinical interrogation of the whole genome, but also providing the results in a turnaround time consistent with the demands of patient care. This is a game-changer that will revolutionize our field,” said Dr. Leonard Sender, Medical Director, CHOC Hyundai Cancer Institute and Director of the Young Adult Cancer Program at the University of California, Irvine Chao Family Comprehensive Cancer Center.

Initially, the rapid turnaround option is available with limited capacity, and cases will be prioritized by severity in consultation with ordering physicians. Later this year, Illumina will begin offering focused clinical interpretation for CLIA services, working closely with ordering physicians and leveraging bioinformatics tools and internal medical genetics expertise.

About Illumina

Illumina (www.illumina.com) is a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function. We provide innovative sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein. We also provide tools and services that are fueling advances in consumer genomics and diagnostics. Our technology and products accelerate genetic analysis research and its application, paving the way for molecular medicine and ultimately transforming healthcare.

Forward-Looking Statements

This release contains forward looking statements that involve risks and uncertainties. Examples of forward-looking statements include, but are not limited to, statements we make regarding the expected timing of offering focused clinical interpretation for CLIA services. Important factors that could cause actual results to differ materially from those in any forward-looking statements include challenges inherent in developing, manufacturing, and launching new products and services and the other factors that are 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 do not intend to update any forward-looking statements after the date of this release.

Source: Illumina, Inc.

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