Illumina Launches TruSight Tumor 170

Newest Addition in Clinical Cancer Research Portfolio Aims to Establish a Standardized Method for Tumor Profiling

Illumina, Inc. (NASDAQ:ILMN) today announced the launch of TruSight® Tumor 170, a 170 gene next-generation sequencing solution to support the transformation of the tumor-profiling paradigm from a series of single-gene tests to a multi-analyte approach, providing a more thorough picture of a tumor’s genomic landscape.

TruSight Tumor 170 offers an integrated DNA and RNA enrichment-based workflow, targeting cancer-related genetic aberrations, including small variants, gene amplifications, gene fusions, and splice variants. With optimized bioinformatics tools and automation options, laboratories can implement the assay on an in-house, research use only NextSeq® instrument. Designed to support limited nucleic acid input from formalin-fixed, paraffin-embedded (FFPE) samples, TruSight Tumor 170 facilitates efficient evaluation of biomarkers.

“Having broader gene content allows us to improve cancer research by assessing more genes and to identify structural alterations that are important targets for developing therapies,” said pathologist Anthony Magliocco. “We hope these capabilities will improve clinical cancer research by streamlining the testing of solid tumors. Due to the flexibility of the enrichment methodology upon which TruSight Tumor 170 is based, this technology has the potential to serve as a platform for many applications beyond solid tumor profiling.”

“This new assay is poised to help realize the potential of precision oncology,” said John Leite, PhD, Vice President of Oncology at Illumina. “By integrating DNA and RNA into one protocol, clinical researchers are able to accelerate comprehensive analysis of cancer-related variants and maximize the data obtainable from precious specimens. Looking forward, we aim to deploy the underlying assay method at the heart of TruSight Tumor 170 as a universal standard for optimized tissue assessment across a variety of applications with both fixed and customizable panels.”

“We’re committed to delivering the tools that enable a shared vision of personalized oncology,” said Francis deSouza, President and CEO of Illumina. “We believe the introduction of TruSight Tumor 170 will enable research insights that will positively impact cancer patients in the future.”

TruSight Tumor 170 offers broader investigational power:

• Enrichment-based assay that evaluates DNA and RNA in one integrated protocol
• 170 unique genes informed by partnering pharmaceutical companies, academic community leaders, and industry guidance
• Integrated workflow requires only 40ng of DNA and RNA from FFPE samples, allowing more comprehensive testing while preserving precious samples
• Underlying assay method to serve as a standard for optimized tissue assessment across a variety of applications

TruSight Tumor 170 will begin shipping in Q1 2017. For more information, please visit www.illumina.com/TruSightTumor170.

For Research Use Only. Not for use in diagnostic procedures.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.

Use of forward-looking statements

This release contains projections, information about our financial outlook, earnings guidance, and other forward-looking statements that involve risks and uncertainties. These forward-looking statements are based on our expectations as of the date of this release and may differ materially from actual future events or results. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are (i) our ability to further develop and commercialize our instruments and consumables and to deploy new products, services and applications, and expand the markets for our technology platforms; (ii) our ability to manufacture robust instrumentation and consumables; (iii) our ability to successfully identify and integrate acquired technologies, products or businesses; (iv) the future conduct and growth of the business and the markets in which we operate; (v) challenges inherent in developing, manufacturing, and launching new products and services; and (vi) the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, together with other factors 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 undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.

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Illumina, Inc.Investors:Rebecca Chambers, [e-mail]:Jen Carroll, [e-mail]