JPM: Roche, Illumina unveil 15-year cancer diagnostic tie-up

Illumina hq
Roche and Illumina, as well as Roche's Foundation Medicine division, will work to secure regulatory approvals for Illumina’s TruSight Oncology 500 assay as a pan-cancer companion diagnostic for different targeted therapies. (Illumina)

SAN FRANCISCO—Roche has inked a 15-year partnership with Illumina in oncology, which will include collaborating on new companion diagnostic indications for the DNA sequencing giant’s pan-cancer assay.

Announced during the J.P. Morgan Healthcare Conference, the nonexclusive pact will also enable Roche to develop and distribute in vitro diagnostic tests for Illumina’s current and future hardware lines—such as the NextSeq 550Dx and the upcoming NovaSeqDx system. The deal’s financial terms were not disclosed. 

“We are excited Roche has selected Illumina’s sequencers as their platform of choice to accelerate the adoption and broaden the reach of oncology-based, distributable IVD tests into clinical care,” Illumina CEO Francis deSouza said in a statement

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Roche plans to develop, manufacture and commercialize its Avenio cancer test kits for both tissue and blood samples, while Illumina will continue to sell its NextSeq 550Dx systems and core sequencing consumables. Though Avenio panels may be used in pan-cancer applications, they are optimized for lung and colorectal cancers, according to Roche. 

Meanwhile, both companies will work to secure regulatory approvals for Illumina’s TruSight Oncology 500 assay, also known as TSO 500, as a pan-cancer companion diagnostic for different targeted therapies—including previously approved drugs and investigational treatments in Roche’s pipeline.

“This partnership complements and strengthens our strategy to establish TSO 500 as a comprehensive NGS panel for cancer therapies by expanding the supported set of CDx claims on this universal panel,” deSouza said. “Building on the momentum of other recently established diagnostic and pharmaceutical partnerships, together we aim to advance critical access to NGS testing to improve patient outcomes.”

One of the anchors of Illumina’s oncology portfolio, TSO 500 uses both DNA and RNA biomarkers from tumor samples to help identify genetic variants linked to tumor progression. Illumina said it will lead the test’s development and approval process, in addition to manufacturing and commercial work, while Roche will support its development and regulatory filings.

“This collaboration is uniquely positioned to improve medical value and clinical decision making globally by combining the unique capabilities of the Roche Group including Foundation Medicine with Illumina and will provide more patients with access to NGS to characterize their disease and identify the right treatment for them,” said Roche Diagnostics CEO Thomas Schinecker. “This builds upon our strategy of accelerating clinical research, streamlining workflows and expanding assay menus to broaden access to genomic data and lower barriers to routine use.”

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