Our companion diagnostic (CDx) development partnering capabilities supports biopharma partners with CDx solutions to help overcome the challenges associated with identifying the right patient for the right drug in clinical development and after approval for commercialization.
Joint Companion Diagnostic Partnering Solution
We provide end-to-end CDx partnering solutions for our biopharma customers from initial biomarker discovery to commercialization.
Why is Dx Companion Diagnostics Partnering Beneficial?
Increase probability of success for pivotal trials
Potentially accelerate FDA approval of therapeutics
Identify patient populations who may experience benefit from new therapeutics for approved therapeutics in clinical development
Realize greater efficiency in clinical development from faster patient enrollment in clinical trials
Benefit from Biodesix’s flexible regulatory and commercialization strategies that can include a single site and distributed strategy for test commercialization
Benefit from Biodesix’s commercial and reimbursement experience in diagnostics
Why Partner With Us?
We can structure our CDx partnership model to fit your needs
We actively engage in IVD programs in the US and ROW
We provide a multiple technology approach to biomarker discovery, development,regulatory approval and commercialization of diagnostic tests
We have significant experience gaining wide-spread U.S. reimbursement for novel diagnostic tests
We have two laboratories that maintain the highest level of compliance that exceeds the minimal clinical laboratory certification
Contact our biopharma services team to learn more about our capabilities to be your CDx partner
