NGS-based companion diagnostics

Fueling the future of precision oncology

Companion Diagnostics Development

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.

We plan to deliver regulatory compliant solutions to our pharma partners and ultimately to clinical testing laboratories by building on the FDA clearance of the Illumina MiSeqDx 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-cleared 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 robust development roadmap targeting applications in oncology.


Illumina is engaged with leaders of the oncology pharmaceutical industry in an effort to bring a universal oncology test system to market. Since 2014 Illumina has partnered with Amgen, Astra Zeneca, Merck Serono, and Sanofi to realize the value of precision oncology.

The Illumina Illumina Propel Certification Program is a collaborative service partnership. It is dedicated to ensuring you can obtain the highest-quality data available for genetic analysis applications.

Illumina Propel certification provides a competitive advantage for service providers. It ensures that customers who use Illumina Propel services receive the industry-leading data quality and service they have come to expect from Illumina.

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