Companion Diagnostics
A Powerful Partner in Drug Development
PrimeraDx is a molecular diagnostic manufacturer with full-service companion diagnostic (CDx) capabilities. As a drug development partner, we provide full diagnostic support during clinical development and commercialization—so drug developers can capture the full value of their therapies.
What is a Companion Diagnostic?
A companion diagnostic (CDx) is an FDA-approved in vitro diagnostic (IVD) test for a biomarker that is used to select patients for a particular therapy, based on the test’s ability to predict patient response or avoid safety risk.
What is necessary for a successful companion diagnostics partnership between an IVD manufacturer and a drug developer?
To support a drug development program, the CDx provider must:
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Develop the IVD according to FDA guidelines and satisfy global regulatory authorities’ requirements for timely registration
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Manufacture at the anticipated scale
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Deliver the IVD to all territories where the therapeutic is launched
Why choose PrimeraDx?
- The PrimeraDx “All in One Tube” technology makes it possible to develop unique, highly multiplexed, multimodal, quantitative and qualitative IVDs to interrogate dozens of biomarkers in the same reaction simultaneously
- Unlike other CDx providers, PrimeraDx offers a reduced-cost, fixed-price program
- We have deep experience working with drug developers to support therapeutic development
- Our program structures are flexible, valued-based and incorporate risk-sharing
- We are an independent company with no ownership relationship with any drug developers
- PrimeraDx can provide seamless global deployment of investigational use tests and commercial IVDs through our innovative lab partnerships