
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.
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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
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NGS-based liquid biopsy technology in CDxLearn 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 cancerExamine 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 repairA 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 predictionDiscover 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 TestingLearn 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 PerspectiveFind 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 DevelopmentLearn about the value of CTCs in liquid biopsy analysis and CDx development.
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Pathway to NGS IVD developmentDiscover 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 CommercializationFind 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 CDxExplore the role of liquid biopsy and exosomes in biomarker discovery and CDx development.
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.
The value of a Day-One lab network is even broader.
Day-One labs can support:
Day-One labs can support:
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A voucher program to support early patient testing
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Pre-launch non-interventional/ epidemiological studies to generate data on the new biomarker and indication
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Extended Access or Named Patient Programs to enable patient access to innovative treatments
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Early testing experience of lab leaders to facilitate stakeholder communication and publications