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Illumina, Agendia partner to co-develop in vitro diagnostic tests for oncology testing

San Diego
Wednesday, January 12, 2022, 17:30 Hrs  [IST]

Illumina, Inc. announced a multi-year partnership with Agendia N.V., a world leader in precision oncology for breast cancer, 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 MiSeqDx sequencing platform to expand the range of gene panels available for solid tumor analysis. We expect Agendia's flagship test, MammaPrint, which is FDA-cleared and currently offered via Agendia's central laboratory, to be the first decentralized NGS-based breast cancer recurrence risk test cleared by the FDA.

"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."

Illumina's robust diagnostic NGS product portfolio, including the MiSeqDx 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. We believe the decentralized MammaPrint NGS test, developed on the Illumina MiSeqDx platform, will enable major clinical hospitals worldwide to offer the clinical utility and benefits of MammaPrint to their physicians and patients in-house.

"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 is improving human health by unlocking the power of the genome. The company focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets.


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