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.
Global commercialization and day-one lab readinessOur 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:
• Medical communication
• Assay verification
This gives patients immediate access to the test and your drug.