Illumina Announces New and Expanded Oncology Partnerships with Bristol Myers Squibb, Kura Oncology, Myriad Genetics, and Merck to Advance Comprehensive Genomic Profiling

Speaking today at the 39^th Annual J.P. Morgan Healthcare Conference in San Francisco, California, Illumina CEO, Francis deSouza, announced a series of oncology partnerships that aim to expand the reach of its powerhouse comprehensive genomic profiling family of products, TruSight™ Oncology.

TruSight Oncology 500 (TSO 500) is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key somatic variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic (IVD) test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500 and is currently undergoing review with regulatory authorities. It is expected to be launched in both the U.S. and Europe later this year.

“Cancer is a disease of the genome and treatment will increasingly leverage NGS-based tests, from early detection and diagnoses, to therapy selection and monitoring,” said deSouza. “The continued expansion of our TruSight Oncology pipeline complements our planned acquisition of multi-cancer early detection company GRAIL.”

Illumina is leveraging the content of its TSO 500 assay to develop companion diagnostics (CDx). The following partnerships demonstrate Illumina’s commitment to collaborating with industry leaders on cancer diagnostics and the advancement of precision oncology:

• BRISTOL MYERS SQUIBB: Expanding on a collaboration that began in 2018, Bristol Myers Squibb will develop a microsatellite instability CDx, as well as develop a diagnostic based on the content of TruSight Oncology 500 ctDNA, Illumina’s first liquid biopsy assay. Both program expansions are planned for global use by Bristol Myers Squibb’s portfolio of cancer therapeutics.
• KURA ONCOLOGY: Our partnership with Kura Oncology is focused on building a CDx claim for HRAS mutations in Head and Neck Squamous Cell Carcinomas.

Responding to the growing clinical use of PARP inhibitor drugs beyond BRCA-mutant cancers, and toward broader populations of patients with homologous recombination repair deficiency (HRD), Illumina is partnering to further expand the clinical utility of the TruSight Oncology portfolio.

• MYRIAD GENETICS: Illumina is partnering with Myriad, with time-limited exclusivity in certain markets, to develop and commercialize distributed kits for the assessment of HRD and for Myriad to expand its HRD service offerings, through a combination of TruSight Oncology content and Myriad’s myChoice® CDx test.

“The agreement between Myriad and Illumina combines clinically validated companion diagnostics and next-generation sequencing to advance comprehensive genomic profiling of tumor samples and drive improved outcomes for oncology patients,” said Paul J. Diaz, President and CEO, Myriad Genetics. “We are pleased to collaborate with a high-caliber healthcare leader like Illumina to expand international access to the proprietary technology in Myriad’s myChoice CDx test and together bring innovative solutions to the oncology market.”

• MERCK: Additionally, Illumina and Merck are conducting a study focused on the expanded TruSight Oncology HRD offering.

“Illumina remains committed to innovating and diversifying our oncology product portfolio and partnerships. Together we can help rapidly deliver actionable insights to patients and physicians, by removing the empiric nature of therapy selection,” said Joydeep Goswami, Senior Vice President of Corporate Business Development at Illumina. “With sequencing at the forefront of precision medicine, we are inspired by the opportunity that lies ahead with not just these partnerships, but others to come.”

The financial terms of all the deals were not disclosed.

To learn more about TSO 500, click here.

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 connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

Use of forward-looking statements

This release contains forward-looking statements that involve risks and uncertainties, including the expectation for lower costs related to the storing and managing of genomic data costs. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing and launching new products and services; (ii) our ability to successfully manage development and marketing partnerships; (iii) our ability to deploy new products, services, and applications, and to expand the markets for our technology platforms; and (iii) the acceptance by customers of our newly launched products, which may or may not meet our and their expectations once deployed, 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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