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Roche, Illumina Partner on Next-Generation Sequencing IVD, CDx Development, Marketing

SAN FRANCISCO – Roche and Illumina said at the JP Morgan Healthcare Conference here on Monday that they have formed a partnership focused on driving the adoption of next-generation sequencing assays for oncology.

Under the 15-year, non-exclusive agreement with Roche, Illumina will grant Roche rights to develop and distribute in vitro diagnostic tests on Illumina's NextSeq 550Dx System, as well as on its future portfolio of Dx-branded sequencing systems, including the forthcoming NovaSeqDx.

The second part of the partnership will see Roche collaborate with Illumina to expand the claims for Illumina's comprehensive pan-cancer assay TruSight Oncology 500 (TSO 500).

Financial terms of the deal were not disclosed.

In a presentation at the conference Monday morning, Illumina CEO and President Francis deSouza said that the agreement with Roche is in line with similar deals the company has recently made with Qiagen and ArcherDx and dovetails with Illumina's goal to create "the richest NGS testing menu in the world."

"Obviously oncology is a big area for these … and we are hugely excited for the Roche" partnership, deSouza said. "They are a diagnostic powerhouse, but also they have access to pathology labs, clinical labs … but they are also a leading therapeutic provider … that will allow us to expand the diagnostic footprint for the TSO 500. This is the beginning of a very powerful partnership … [and] you can expect us to do more of these types of partnerships."

Further elaborating on the alliance on the sidelines of the JPM conference, Kevin Keegan, senior director of clinical oncology marketing at Illumina, said that the partnership around the TSO 500 is for both on-market and pipeline therapeutics from Roche. Although the companies declined to disclose the list of specific therapeutics at this time, they will be for indications such as lung cancer, melanoma, and breast cancer, for starters.

"The time is now to accelerate patient access to this testing," Keegan said.

From Roche's perspective, teaming up with Illumina provides Roche with a clear and immediate "pathway to in vitro diagnostics [use] for our assays," said Neil Gunn, head of Roche Sequencing. The companion diagnostic component of the partnership will initially focus on "decentralizing" the FoundationOne NGS assay from Roche's Foundation Medicine by leveraging Illumina's worldwide installed base of sequencers.

"That will be the first menu item, with liquid biopsy and other tissue-based assays" to follow, Gunn said.

"This came together relatively fast in an effort to help decentralize [NGS testing] to patients," Gunn said. "We are well set up now to offer [companion diagnostic] testing in both the US and globally."

Importantly, Gunn noted, Roche continues to develop its own sequencing products, including library prep and "back-end" solutions such as informatics, as well as its own sequencing platform. He did not provide additional details on these development activities.

The alliance comes seven years after Roche launched a $5.7 billion hostile takeover bid for Illumina, which Illumina successfully rebuffed.