NGS-based companion diagnostics

Fueling the future of precision medicine

Companion Diagnostics Development

The emergence of targeted therapies in oncology and other disciplines has increased the need for companion diagnostic tests. By providing detailed biomarker information through a multi-analyte approach, next-generation sequencing (NGS) is an ideal method for bringing precision medicine closer to everyday clinical practice.

In partnership with leading pharmaceutical companies and the oncology community, we are 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 are delivering companion diagnostic solutions to our pharmaceutical partners and clinical testing laboratories by building on the status of the Illumina MiSeqDx System as the first FDA-regulated and CE-IVD-marked NGS instrument for use in in vitro diagnostic procedures. We continue to leverage advances in NGS technology to develop clinical tests that inform diagnosis and treatment.

We are committed to bringing the power of NGS to clinical diagnostics. The FDA-regulated and CE-IVD-marked MiSeqDx System offers an ideal platform to perform NGS-based assays. With its small benchtop footprint and easy-to-use interface, the MiSeqDx instrument delivers data output tailored to the needs of clinical labs.

We offer cystic fibrosis assays and a companion diagnostic for RAS mutational testing in colorectal cancer to determine eligibility for Vectibix® treatment.* Clinical labs can also use the MiSeqDx System and the TruSeq Custom Amplicon Kit Dx to develop their own diagnostic assays.

We intend to expand the menu offered on the MiSeqDx System through a development roadmap targeting applications in oncology.

*Vectibix is a registered trademark of Amgen, Inc.


We are engaged with leaders of the oncology pharmaceutical industry in an effort to bring companion diagnostic solutions to market.

Since 2014, we have partnered with multiple pharmaceutical companies, including Amgen, Astra Zeneca, Merck Serono, and Sanofi, to realize the value of precision oncology.

Learn more about our partnerships

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Some NGS discoveries have become the basis for developing companion diagnostics now in use in molecular diagnostic laboratories worldwide. These laboratories are now faced with an evolving landscape of regulations and reimbursement strategies for NGS oncology testing.

We spoke with several key opinion leaders about the ongoing challenges and potential of NGS in oncology.

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The Changing Landscape of NGS Implementation in Molecular Diagnostic Laboratories
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How Genomics is Shaping the Future of Oncology
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Read an interview with John Leite, VP of Marketing for Illumina’s Oncology business.

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RNA-Seq for Drug Response Biomarker Discovery and Profiling

Access resources to explore NGS-based biomarker discovery and profiling.

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