Illumina Launches TruSight® Tumor OncoPanel

Focused Panel Sets the Groundwork for Illumina Oncology Program

SAN DIEGO--(BUSINESS WIRE)--Sep. 29, 2015-- Illumina, Inc. (NASDAQ:ILMN) today announced it has launched TruSight® Tumor 15, a next-generation sequencing (NGS) panel designed to identify sequence variants in 15 genes commonly associated with marketed therapeutics. TruSight Tumor 15 is optimized for low input DNA from tissue preserved in formalin and paraffin.

“In 2014, Illumina catalyzed the Actionable Genome Consortium (AGC), bringing together thought leaders to define the standards and content for NGS panels intended for use in oncology applications,” said Francis deSouza, President of Illumina. “The TruSight Tumor panel represents the first product, intended for research use only, based on the initial standards defined by the AGC and pharma partners, enabling researchers to advance the application of NGS in this important field.”

The new sequencing panel is optimized for damaged and degraded formalin-fixed, paraffin embedded (FFPE) tumor samples, enabling low frequency somatic variant detection from limited nucleic acid inputs. When paired with the Illumina MiSeq® system, the panel delivers high-quality sequencing with key content and features needed for tumor analysis in translational research.

Illumina is committed to collaborating with pharma partners, the Actionable Genome Consortium, regulatory agencies and key opinion leaders to establish best-practices and consensus standards in NGS testing.

“Tumor biopsies are collecting ever smaller amounts of cancer tissue and the fixation and preservation of the material results in degraded DNA. The challenge for scientists has been to get sufficient intact DNA to efficiently identify the key genetic drivers,” said John Leite, Ph.D., Vice President of Oncology at Illumina. “This new panel is designed to reduce the resource burden on small and medium-sized labs by offering a simple, accurate and fast solution that addresses tissue considerations on the front end and provides streamlined analytics on the back end.”

Dr. Jamie Platt, Vice President of Genomic Solutions at Molecular Pathology Laboratory Network, Inc., evaluated the product in beta testing and said the panel’s simplicity and ease of use makes it well-suited for translational labs, “The value and appeal of next-generation sequencing is the potential to consolidate traditionally iterative tumor analyses. Our evaluation of the new TruSight Tumor 15, with its streamlined library prep and sequencing workflow, gives us confidence that this application is ideal for deployment. Even our most challenging samples produced results, including those with low nucleic acid inputs, giving us assurance we can analyze our most precious specimens.”

TruSight Tumor 15 offers a sample-to-data solution for research of common somatic variants.

• Simple sample-to-data workflow optimized for the MiSeq instrument will drive greater lab operational efficiency by replacing the cost and resource intensive practice of iterative single gene analysis.
• Focused gene content was informed by pharmaceutical partners, an independent consortia of key opinion leaders and the needs of pharmaceutical clinical researchers to identify relevant somatic variants in common solid tumors.
• Streamlined multiplex PCR-based library prep method, with limited hands on time, produces high-quality data in approximately 36 hours from extracted DNA to result.
• Highly sensitive assay detects somatic mutations at 5 percent variant frequency and maximizes sample success with 20 ng of DNA isolated from FFPE samples.

TruSight Tumor 15 is available for order now and will ship in Q4 2015. For more information, visit www.illumina.com/OncologyPanel.

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

About Illumina, Inc.

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.

Forward-Looking Statements

This release may contain forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those in any forward-looking statements 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.

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Source: Illumina, Inc.

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