Multi-year partnership to advance the use of next-generation sequencing for decentralized oncology testing, to bring improved insights to patients with breast cancer globally

Agendia, Inc., a commercial stage company focused on precision oncology for breast cancer, today announced a multi-year partnership with Illumina, Inc. (NASDAQ: ILMN), to co-develop in vitro diagnostic (IVD) tests for oncology testing. The partnership is intended to advance the use of next-generation sequencing (NGS) for decentralized oncology testing and aligns with Illumina’s approach to IVD partnerships in oncology. Agendia joins Illumina’s growing portfolio of more than 30 IVD partners developing over 40 sequencing-based solutions for cancer prognosis, therapy selection, and other applications.

Illumina and Agendia plan to develop new tests to enhance the care and management of breast cancer patients, utilizing the Illumina MiSeq™Dx sequencing platform to expand the range of gene panels available for solid tumor analysis. The company expects its flagship test, MammaPrint®, which is FDA-cleared and currently offered via Agendia’s central laboratory, will be the first decentralized NGS-based breast cancer recurrence risk test cleared by the FDA.

“This partnership represents a major step in Agendia’s integration of NGS technologies and brings us even closer to our promise of providing crucial genomic information to physicians and their patients to guide care at every single step in a patient’s treatment journey,” said Mark Straley, Chief Executive Officer of Agendia. “We believe our current FDA-cleared, broadly reimbursed MammaPrint test provides the perfect foundation for incorporation with Illumina’s MiSeqDx platform. Together, we plan to expand what is possible in breast cancer care and ensure that the essential insights that come from genomic testing are delivered to patients around the world.”

Illumina’s robust diagnostic NGS product portfolio, including the MiSeq™Dx platform, covers a broad range of clinical applications designed for a variety of clinical lab settings. As NGS testing becomes more integrated in routine patient care, Illumina is committed to providing clinical solutions, through both products and partnerships, that enable the diagnosis and management of human diseases.

Agendia’s proprietary testing solutions empower physicians to more accurately diagnose the disease drivers and predict the progression of a woman’s breast cancer. The company’s scientific approach provides a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to personalize treatment. The company believes the decentralized MammaPrint NGS test, developed on the Illumina MiSeq™Dx platform, will enable major clinical hospitals worldwide to offer the clinical utility and benefits of MammaPrint to their physicians and patients in-house. In addition, the MammaPrint NGS test will leverage nearly two decades of clinical evidence drawn from 30 clinical studies featuring over 30,000 patients with breast cancer, as well as a 15-year history of FDA clearance, top tier medical society guideline inclusion, and well-established and unique CPT codes for broad reimbursement.

“We are pleased to partner with Agendia, with its deep expertise in genomic testing in breast cancer, to expand the reach of NGS-based genomic testing in cancer care,” said Joydeep Goswami, Chief Strategy and Corporate Development Officer of Illumina. “We believe enabling in-house clinical testing will strengthen the knowledge of the healthcare network, reduce turnaround times, and ultimately better support more patients with improved guidance on care pathways.”

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling state-of-the-art decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint® and BluePrint® provide a holistic view of an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.

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