Illumina Unveils Strategic Roadmap for Market Expansion

Company Positions for Growth in Key Genomics Segments, Introduces New Workflow Solutions at Investor Day

SAN DIEGO--(BUSINESS WIRE)--Jan. 16, 2014-- Illumina, Inc. (NASDAQ:ILMN) today unveiled a strategic roadmap for moving next-generation sequencing (NGS) into new markets, leveraging its technology leadership and new organizational alignment around those markets to drive growth. During an investor day where executives presented plans for this growth, Illumina also shared workflow innovations designed to simplify the sequencing experience and new market solutions derived from the company’s sample to answer technology base.

“Earlier this week we announced two transformative platforms that redefine next-generation sequencing, with the addition of the NextSeq™ 500 System and the HiSeq® X Ten to our market leading portfolio. Today we previewed additional innovations that position us to seize opportunities across research and clinical markets, as well as to deliver the industry’s simplest, most efficient sequencing experience to our customers,” said Jay Flatley, Illumina’s Chief Executive Officer.

Expanding the Use of Next-Generation Sequencing (NGS)

Illumina shared the following strategies and innovations around its core market targets.

• In reproductive health, Illumina will expand its offerings based on the verifi® laboratory-developed non-invasive prenatal test (NIPT), submitting an IVD version on the HiSeq® 2500 system for FDA premarket approval by the end of 2014. It also will offer an NGS-based solution for preimplantation genetic screening, VeriSeq™ PGS, launching initially on the MiSeq® system, as well as an array-based karyomapping single gene preimplantation genetic diagnosis (PGD) solution to identify embryos with genes associated with severe genetic disorders.
• In oncology, the company previewed a targeted sequencing strategy that includes supporting the clinical community with content. Illumina is also working in collaboration with the oncology community to develop test guidelines and infrastructure to build actionable cancer genomics solutions.
• In emerging markets, Illumina will launch a human leukocyte antigen (HLA) typing product in mid-2014 for laboratories seeking next-generation sequencing on the MiSeq® platform that will be faster, less expensive, and more accurate than current technologies. Additionally, the company introduced the MiSeq® Forensic Genomics System (MiSeq FGx), the first targeted forensic NGS system, which will simultaneously interrogate short tandem repeats and other valuable genetic markers to provide more comprehensive identification information from both challenging and standard biological samples. The complete sample to answer solution, including consumables and software, is expected to be available in the first six months of 2014.

Simplifying the Sample to Answer Experience

Illumina previewed the following products that simplify the end-user experience for sample preparation and analytics and further solidify the technology tool kit that can be used across markets to address customers’ needs for integration.

• NeoPrep™ is a push-button library preparation system that provides a radically simpler workflow to go from DNA or RNA to libraries ready for sequencing. It will prepare up to 16 libraries per run, starting from as little as 1ng of input for some assays. The first kits for NeoPrep will be TruSeq PCR-Free and TruSeq Nano, with other TruSeq and Nextera kits to follow. NeoPrep, expected to be available summer 2014, is an important step on the path to offering integrated, sample to answer solutions.
• BaseSpace® OnSite provides the BaseSpace® experience in a simple informatics appliance, enabling NGS users to securely stream data directly to a local solution for storing, analyzing, and interpreting genomic sequence data. BaseSpace® Onsite represents a turnkey solution and will be available in the first quarter of 2014.
• BaseSpace® Core Apps transform sequence data processing into a simple push-button process for the most frequently used sequencing applications. These highly optimized apps eliminate time spent configuring and maintaining software, and support RNA-sequencing, exome analysis, whole genome sequencing, and tumor/normal analysis. BaseSpace® Core Apps are available for BaseSpace® including BaseSpace® Onsite.

Paving the Way for Genomics in the Clinic

In November 2013, Illumina became the first company to receive FDA premarket clearance for a next-generation sequencing platform with its MiSeqDx system. Illumina will continue to pave the way for NGS in regulated markets with further submissions to the FDA, beginning with NIPT on the HiSeq® 2500, while also driving standards for the use of NGS in the clinic. In addition, the company will continue to build the infrastructure and means with which to deliver a best-in-class regulated products pipeline through its IVD Development group.

“Illumina’s technology is already making an impact in identifying undiagnosed diseases, and we will soon see it transforming fields like oncology and complex disease,” said Francis deSouza, President of Illumina. “The strategic roadmap presented today demonstrates our commitment to making NGS ubiquitous across markets, delivering simplified and integrated solutions to our customers, and paving the way for a new era in health care.”

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 availability dates for new products and services and FDA submission dates and intentions for certain products and 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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