Deciding on a companion diagnostic (CDx) partner with a proven track record in IVD development is crucial for successful CDx-drug co-approval. Your CDx partner also needs to have global regulatory capabilities and, most importantly, global commercialization expertise through an industry-leading day-one lab readiness network. As a leader in molecular CDx development, we deliver a proven IVD development process across multiple technologies (PCR + NGS) plus commercialization expertise, ensuring global registration success and the best test access at the time of your drug approval – in any market.
Flexibility to meet pharma CDx needs
In the dynamic world of CDx, one size does not fit all. Utilizing QIAGEN’s breadth of technology spanning across digital PCR (dPCR), PCR and NGS,* you have the flexibility to tailor a CDx program to your needs. No other partner provides you with an extensive suite of platforms, enabling you to select the right solution for your clinical use case. Using this customized offering coupled with a comprehensive launch readiness framework and large global footprint in molecular labs, we support you through the entire development process – from idea through to global commercialization.
* NGS: QIAGEN has entered into a 15-year partnership with Illumina for the development of IVD assays on their Dx instruments (miSeqDx, NextSeqDx, NovaSeqDx).
View our on-demand webinars
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HRR and HRD: The role of DNA damage repair
A defective DNA damage repair mechanism is often associated with cancer. Learn how the QIAseq HRD panel can provide deeper insights in homologous recombination deficiency.
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Signaling pathway CDx for therapy response prediction
Discover how QIAGEN and Philips are partnering to develop companion diagnostics based on OncoSignal pathway activity tests for therapy response prediction.
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Exosome-based dPCR for FGFR Testing
Learn how an innovative therascreen workflow that combines exosome-based liquid biopsy and digital PCR was used for FGFR testing (currently in development) in bladder cancer.
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IVD-R Impact and CDx Industry Perspective
Find out why the new European IVDR is a game changer for companion diagnostics (CDx) and the testing landscape.
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Liquid Biopsy: Minimally Invasive CDx Development
Learn about the value of CTCs in liquid biopsy analysis and CDx development.
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Pathway to NGS IVD Development
Discover how customized panels from QIAGEN can put you on a clear path for the development of in vitro diagnostics.
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Real-World Insights and Global CDx Commercialization
Find out how QIAGEN advanced real-world evidence can help you and learn how to prepare a network of leading laboratories for day-one readiness.
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Liquid Biopsy- and Exosome-based CDx
Explore the role of liquid biopsy and exosomes in biomarker discovery and CDx development.
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HRR and HRD: The role of DNA damage repair
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Signaling pathway CDx for therapy response prediction
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Exosome-based dPCR for FGFR Testing
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IVD-R Impact and CDx Industry Perspective
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Liquid Biopsy: Minimally Invasive CDx Development
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Pathway to NGS IVD Development
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Real-World Insights and Global CDx Commercialization
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Liquid Biopsy- and Exosome-based CDx
Global commercialization and day-one lab readiness
Our wealth of experience with regulatory authorities worldwide means we can navigate the regulatory path, satisfy regulatory requirements and drive your success. Some companion diagnostic partners lack the experience and access to a global commercialization channel. We work with you to develop a commercialization strategy, from development through to launch – and ensure broad access to testing.
We deliver a streamlined, seamless workflow – from idea through to globalization and day-one readiness. Our Day-One Lab Readiness program is not only an important tool for global commercialization but also vital to ensure day-one access for patients to innovative CDx tests at the time of your drug approval. This program includes:
• Medical communication
• Assay verification
• Reimbursement
This gives patients immediate access to the test and your drug.
With our global presence, we can meet your country-specific commercial requirements .