Partnering for precision diagnostics

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).

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Did you know, your CDx can be registered in up to 190 countries?
IVD Development

Broad expertise in IVD development

Our proven expertise in CDx development means we are uniquely positioned to give you access to a breadth of IVD solutions across multiple analytes (plasma, DNA and RNA) and multiple technologies (from qPCR to NGS). Our global Centers of Excellence for CDx development leverage our strengths and know-how to develop your CDx workflow successfully. But our partnership does not end here…
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Today, we have 40 NGS panels used by 1200+ customers worldwide and 9 PCR CDx approvals.

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.

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:

• Pre-approval preparation and implementation
• Medical communication
• Forecasting
• Assay verification
• Training

• Reimbursement

This gives patients immediate access to the test and your drug.

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Discover how QIAGEN can drive the successful development and global commercialization of your CDx solution
  • Liquid Biopsy: Minimally Invasive CDx Development
    Learn about the value of CTCs in liquid biopsy analysis and CDx development.
    Liquid Biopsy: Minimally invasive CDx development webinar 1
  • 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.
    NGS panel to IVD webinar 2
  • 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.
    Real-world insights and global CDx commercialization webinar 3
  • 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.
    IVD-R Impact and CDx Industry Perspective
  • Liquid Biopsy- and Exosome-based CDx
    Explore the role of liquid biopsy and exosomes in biomarker discovery and CDx development.
    Liquid Biopsy- and Exosome-based CDx
  • Importance of Global Commercial Reach
    Discover how our global commercial reach enables CDx commercialization in all major markets.
    Importance of Global Commercial Reach
  • Liquid Biopsy: Minimally invasive CDx development webinar 1
    Liquid Biopsy: Minimally Invasive CDx Development
  • NGS panel to IVD webinar 2
    Pathway to NGS IVD development
  • Real-world insights and global CDx commercialization webinar 3
    Real-World Insights and Global CDx Commercialization
  • IVD-R Impact and CDx Industry Perspective
    IVD-R Impact and CDx Industry Perspective
  • Liquid Biopsy- and Exosome-based CDx
    Liquid Biopsy- and Exosome-based CDx
  • Importance of Global Commercial Reach
    Importance of Global Commercial Reach
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