BIOTECHNOLOGY

Just in time for the start of the JP Morgan conference, Roche and Illumina, the competitors in the emerging market of NGS-based cancer patient stratification and therapy decision support announced a long-term non-exclusive partnership “to broaden cancer patient access to genomic testing”. Both companies’ goal is to genomically define a patient’s unique cancer and use the genomic pattern to match optimal treatment. According to the new partners, “understanding of the genomic drivers of cancer based on NGS tumour profiling has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring”.

No financial details were announced by the companies but the collaboration of the world diagnostics market leader Roche and NGS market leader Illumina targets a huge market opportunity: NGS-based cancer therapy decision support at every cancer centre in the world.

Under the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer blood assay TruSight Oncology 500 (TSO 500) with new companion diagnostic (CDx) claims.

It’s Illumina’s second strike in positioning its next sequencing-(NGS) based TruSight Oncology 500 (TSO 500) tumour-profiling assay (which has been granted "FDA-breakthrough device" status) as diagnostic standard for known and new solid tumour biomarkers and clinical decision making, particularly in the growing field of immuno-oncology. In October 2019, Illumina announced a 15-year partnership with Qiagen axing the company’s distribution of Gene Reader sequencing hardware and letting depart CEO Peer Schatz in order to collaborate in the lucrative oncology and immunooncology companion diagnostics space. Analysts from Energias Market Research predict that market will grow from US$3.2bn in 2018 to about US$10.6bn in 2025.

Under the IVD terms of the agreement with Illumina, Roche will develop, manufacture and commercialise Avenio IVD tests for both tissue and blood for use on Illumina’s NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Roche and Illumina will develop and pursue CDx claims on TSO 500 for both existing and pipeline Roche oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process and will continue to manufacture, supply and commercialise TSO 500. Roche will support the development of the claims and regulatory filings.

For the current competitors of Illumina in the NGS-based diagnostics market, Thermo-Fisher, Agilent Technologies, and MolecularMD, the deal is an earthquake that will expand the reach of Roche/Foundation Medicine’s platform for data and clinical decision support to help patients receive optimal cancer therapy through Illumina’s huge clinical NGS market penetration.

Roche, however, is interested to integrate more diagnostic information, beyond the reach of NGS testing into a cancer decision support software, i.e. from tumour imaging.

“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 characterise their disease and identify the right treatment for them,” said Thomas Schinecker, CEO of Roche Diagnostics. “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.”

Roche subsidiary Foundation Medicine offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Roche Sequencing Solutions provide reagents and software needed for labs to determine the genomic characteristics of solid and liquid-based samples through a single DNA workflow.

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