
A successful CDx launch has three key elements…
- FDA-drug approval for the targeted therapy
- A validated diagnostic (an assay, a molecular study, gene sequencing)
And what’s often overlooked…
- Effective training for sales reps, laboratory personnel, and physicians.
Successful development of a companion diagnostic doesn’t guarantee its adoption, and it can’t be assumed. Innovative technologies impact lab practices and overall workflow. The roles of the pathologist and oncologist are redefined. Ultimately, it reshapes how patient care is delivered, and that can’t happen when folks are unsure of what they’re doing.





