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A test approved to select patients for a drug in the US must go through separate approval in Europe, Japan and elsewhere, delaying the drug. Accepting each other's test approvals would fix the delay.
Companion diagnostics are regulated separately from drugs and differently by region (FDA premarket approval, EU IVDR, PMDA). Divergence delays drug access and multiplies bridging studies. A mutual-recognition agreement for companion diagnostics among ICH-aligned regulators, analogous to Project Orbis for drugs, with a shared analytical validation dossier and a single bridging-study standard, would remove months to years of delay.
Shares Companion diagnostic, Companion diagnostics, Regulatory divergence between regions, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Biomarkers are not validated or standardised.