The test is currently FDA-cleared and available through the central laboratory of Agendia. Credit: National Cancer Institute, Daniel Sone / Unsplash.

Illumina and Agendia have entered a multi-year collaboration to jointly develop in vitro diagnostic (IVD) tests for oncology testing as well as offer enhanced insights to breast cancer patients. 

The alliance aims to progress the use of next-generation sequencing (NGS) for decentralised testing and is consistent with the approach of Illumina to oncology IVD collaborations. 

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Leveraging the Illumina MiSeqDx sequencing platform, the companies intend to develop new diagnostics to improve breast patient cancer care and management.

The platform will enable the expansion of various gene panels that are available to analyse solid tumours.

With the decentralised MammaPrint NGS test created on the Illumina MiSeqDx platform, key clinical hospitals across the globe will be able to deliver the clinical utility and advantages of the test to physicians as well as patients.

Agendia’s test could become the first decentralised NGS-based breast cancer recurrence risk test to obtain clearance from the US Food and Drug Administration (FDA).

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Agendia CEO Mark Straley said: “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.”

With the partnership, Agendia will be part of Illumina’s portfolio of more than 30 IVD partners that develop sequencing-based solutions for the prognosis of cancer, therapeutic selection and various other applications.

In addition to the MiSeqDx platform, the diagnostic NGS product portfolio of Illumina includes a range of clinical applications intended for various clinical lab settings. 

Last August, Illumina concluded the acquisition of Grail in a deal worth $8bn in order to expedite patient access to the latter’s multi-cancer test.

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