Partnering for precision diagnostics

Partnering for precision diagnostics

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

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.

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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