The emergence of targeted therapies in oncology brings an increased need for companion diagnostic tests. Next-generation sequencing (NGS) is an ideal solution to transform the tumor profiling paradigm from a series of single gene tests to a multi-analyte approach to delivering precision oncology.
In partnership with leading pharmaceutical companies and the oncology community, Illumina is developing a universal oncology test system that aims to deliver a comprehensive set of the currently actionable and emerging biomarkers relevant to cancer drug development.
In the future, we plan to deliver regulatory compliant solutions to our pharma partners and ultimately to clinical testing laboratories by building on the Illumina MiSeqDx's status as the first FDA-regulated NGS instrument for use in in vitro diagnostic procedures. We will also leverage innovative library preparation, sequencing, and informatics solutions to enable powerful biological analysis, fueled by next-generation sequencing.
Illumina is bringing the power of NGS to clinical diagnostics. The CE-marked and FDA-regulated MiSeqDx System offers an ideal platform to perform these NGS-based assays. With its desktop footprint and easy-to-use interface, the MiSeqDx instrument delivers data output tailored to the needs of clinical labs. Already, two cystic fibrosis assays are in use by clinical laboratories. The MiSeqDx system and the Universal Kit provide a foundation upon which Illumina plans to build a menu of clinical solutions.
Illumina intends to expand the menu offered on the MiSeqDx through a development roadmap targeting applications in oncology.
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