Press Release

Memorial Sloan Kettering Cancer Center and Illumina Launch Comprehensive Circulating Tumor DNA Program

Collaboration Aims to Determine Range of Opportunities for Non-Invasive Cancer Diagnosis and Monitoring

NEW YORK & SAN DIEGO--(BUSINESS WIRE)--Sep. 16, 2015-- Memorial Sloan Kettering Cancer Center (MSK) and Illumina, Inc. (NASDAQ: ILMN) today announced a collaboration to conduct research studies that are critical to understanding the biology of circulating tumor DNA (ctDNA). The studies aim to inform the development of new strategies to diagnose and monitor cancer and to help establish ctDNA as an important marker in the study and eventual treatment of cancer.

Traditional biopsies for acquiring tumor DNA are typically invasive and risky and are often not possible. Additionally, single biopsies may not be able to measure the heterogeneity that is often present in tumors. Fortunately, scientists have discovered that dying tumor cells release small pieces of their DNA into the bloodstream. These pieces are called cell-free circulating tumor DNA (ctDNA)1 and can be detected in a blood sample via DNA sequencing2.

As global leaders in cancer care and in next-generation sequencing, MSK and Illumina will conduct research trials designed to answer biological and clinical questions about ctDNA in multiple cancer types. MSK will collect samples, and Illumina will apply its best-in-class sequencing technology to detect ctDNA in those samples. The program will work to validate a ctDNA assay to demonstrate correlation between ctDNA signal and cancer burden.

“The possibility of reducing the number of invasive and expensive diagnostic and monitoring procedures with a simple blood draw is a game-changer for cancer patients and for oncology,” said Jose Baselga, MD, PhD, Physician-in-Chief and Chief Medical Officer at MSK.

“This relationship between Illumina and MSK will create important data regarding the value, the significance and the potential applications of measuring ctDNA via deep sequencing,” said Dr. Rick Klausner, SVP and Chief Medical Officer of Illumina. “Is ctDNA not simply equivalent to, but superior to current methods of cancer diagnosis and monitoring? Can we replace expensive and invasive monitoring with a blood test? Does ctDNA reflect the total burden of cancer clones, and is it equivalent to or better than biopsies at predicting outcome and therapeutic response? These are the types of questions we will work towards answering.”

About Memorial Sloan Kettering

We are the world’s oldest and largest private cancer center, home to more than 13,000 physicians, scientists, nurses, and staff united by a relentless dedication to conquering cancer. As an independent institution, we combine 130 years of research and clinical leadership with the freedom to provide highly individualized, exceptional care to each patient. And our always-evolving educational programs continue to train new leaders in the field, here and around the world. For more information, go to www.mskcc.org.

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.

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.

1 Definition of ctDNA from National Human Genome Research Institute, link accessed on August 19, 2015. 2 Bianchi, DW, et al, JAMA. 2015 Jul 14; 314(2):162-9.

Source: Illumina, Inc.

MSK
Caitlin Hool, 212-639-3573
hoolc@mskcc.org
or
Illumina, Inc.
Investors:
Rebecca Chambers, 858-255-5243
rchambers@illumina.com
or
Media:
Jennifer Temple, 858-882-6822
pr@illumina.com

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