Companion Diagnostics

A Powerful Partner in Drug Development

Companion Diagnostics partnership with PrimeraDx

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:

  • Develop the IVD according to FDA guidelines and satisfy global regulatory authorities’ requirements for timely registration

  • Manufacture at the anticipated scale

  • 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
Contact us to learn more.