Companion Diagnostics Development
Transforming clinical practice with companion diagnostics
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.
Expanding Clinical Menu
We are committed to bringing the power of NGS to clinical diagnostics by offering cystic fibrosis assays and providing the means for clinical labs to develop their own diagnostic assays.
We intend to continue expanding our menu of offerings through a development roadmap targeting applications in oncology.
Leading Pharmaceutical Partners
We are engaged with leaders of the 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, and Sanofi, to realize the value of precision oncology.
NGS and Companion Diagnostics Development
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.
Read Interview
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Additional Resources
NGS Used for Biological QC in BioPharma Production
Read how Merck Serono uses NGS for cell line stability testing and biosafety monitoring.