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www.fdanews.com/articles/166605-illumina-to-develop-oncology-tests-with-astrazeneca-janssen-and-sanofi

Illumina to Develop Oncology Tests With AstraZeneca, Janssen and Sanofi

August 21, 2014

San Diego-based Illumina has teamed with AstraZeneca, Janssen Biotech and Sanofi to develop a universal next-generation sequencing-based oncology test system. The system will be used in clinical trials of the partners’ cancer therapies, as well as in the downstream molecular pathology market, says Naomi O’Grady, senior product manager for oncology.

The companies hope to transition from using multiple companion diagnostics to single panel-based assays that select for companion therapeutics, according to Illumina.

Development is already underway. “We plan to deliver a panel to our pharma partners to enable their clinical investigation in the first half of 2015 and then build on that with further content early in 2016,” O’Grady told Device Daily Bulletin Thursday.

The partnership has the potential to deliver an unprecedented amount of clinical information from a single test, said Ruth March, vice president of personalized healthcare and biomarkers at AstraZeneca.

As Illumina’s partners complete their trials, the company will build on the clinical utility of the panel, O’Grady said. “By enabling our pharma partners with a universal, NGS-based oncology test system, we have the opportunity to deliver a standardized approach that seeks to inform a variety of therapeutics.”

In addition to the partnership with pharma, Illumina said it is working to set standards for NGS-based assays in routine clinical oncology practice and establish regulatory outlines for the new testing standard. — Kellen Owings

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