Partnering for precision diagnostics

Partnering for precision diagnostics

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Advance your CDx development in hereditary diseases
Explore how we are broadening the scope of our companion diagnostics (CDx) into hereditary diseases. Our global partnership with Helix brings you CDx development across a range of hereditary diseases in all clinical trial phases.
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Your partner from development to commercialization

Choosing a companion diagnostic (CDx) partner with a proven track record in IVD development is crucial for successful CDx–drug co-approval. Your CDx partner needs global regulatory capabilities coupled with global commercialization expertise through a day-one lab readiness network.

QIAGEN is a leader uniquely positioned in molecular CDx development. Our proven IVD development process delivers IVD solutions with multiple analytes and multiple technologies. Furthermore, our longstanding commercialization expertise ensures global registration success and optimal test access at drug approval – in any market.

Flexibility to meet pharma CDx needs

In the dynamic world of companion diagnostics, one size does not fit all. QIAGEN’s breadth of technology spans digital PCR (dPCR), real-time PCR and next generation sequencing (NGS*). This provides true flexibility in tailoring a CDx program to your needs and enabling you to select the right solution for your clinical use case. Together with a comprehensive launch readiness framework and large global footprint in molecular labs, this means 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).

Flexibility to meet pharma CDx needs
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NGS panels used

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NGS customers worldwide

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CDx can be registered and commercialized in >190 countries

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PCR CDx FDA approvals

View our on-demand webinars

NGS-based liquid biopsy technology in CDx
NGS-based liquid biopsy technology in CDx
Learn more about QIAGEN and Sysmex Inostics’ partnership to develop ultra-sensitive NGS liquid biopsy technology in companion diagnostics.
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FGFR testing in urothelial cancer
FGFR testing in urothelial cancer
Examine the significance of FGFR alterations and discover how FGFR testing can be leveraged to identify patients who may be eligible for treatment with erdafitinib.
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HRR and HRD: The role of DNA damage repair
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
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
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
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
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
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
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
Liquid Biopsy- and Exosome-based CDx
Explore the role of liquid biopsy and exosomes in biomarker discovery and CDx development.
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Day One testing is crucial for patients

Watch Dr. Lawrence Weiss, Chief Medical Officer at NeoGenomics explain the positive impact that Day One testing can have with respect to patients' treatment. Discover how QIAGEN, NeoGenomics and Novartis came together to enact the optimal Day One scenario.

Day-One testing matters

Patients need access to testing immediately after a drug is launched in any country. We work with our pharma partners to ensure that companion diagnostic testing is available at drug launch in each target market.

Our commercial teams are in place in 25 countries, and we work with partners in more than 60 countries.

Our comprehensive Day-One lab readiness program facilitates CDx testing at drug launch via a global network of partner labs. Implementation and validation of a new test at our partner labs begins several months before CDx and drug approval. In parallel, we run a reimbursement program and align launch communications with our strategic partners with the goal of rapidly ramping-up testing in shortest timeframe post-approval.

World mapWith our global presence, we can meet your country-specific commercial requirements .

The value of a Day-One lab network is even broader.
Day-One labs can support:

A voucher program to support early patient testing
A voucher program to support early patient testing
Pre-launch non-interventional/ epidemiological studies to generate data on the new biomarker and indication
Pre-launch non-interventional/ epidemiological studies to generate data on the new biomarker and indication
Extended Access or Named Patient Programs to enable patient access to innovative treatments
Extended Access or Named Patient Programs to enable patient access to innovative treatments
Early testing experience of lab leaders to facilitate stakeholder communication and publications
Early testing experience of lab leaders to facilitate stakeholder communication and publications

Global commercialization

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.

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