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CDx development

Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.

The recent failure of Bristol-Myers Squibb's lung cancer immunotherapy to meet its primary endpoint demonstrates the challenge of working with imperfect biomarkers.

Dako developed the PD-L1 CDx very specifically to fit Keytruda's mechanism and patients' outcomes to the drug.

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