Agendia, Inc. announced a multi-year partnership with Illumina, Inc. 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 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. 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.