The FDA's 2024 LDT rule was vacated in March 2025 and formally rescinded in September 2025. Here is where US…
How oncology biomarker tests are adopted in England: Genomic Laboratory Hubs, the National Genomic Test Directory, how PD-L1 and other…
A companion diagnostic gates access to a drug; a complementary diagnostic informs the decision without being required. We set out…
How the EU IVDR applies to companion diagnostics: class C rules, the mandatory EMA consultation, the current transition deadlines, the…
Companion diagnostics often run behind the drug programme. Here is why CDx development falls behind, what a parallel drug and…
A pillar guide to companion diagnostics: the FDA definition and approval pathways, EU IVDR class C rules and transition dates,…
300+ senior leaders. Two streams. One agenda: advancing precision oncology.
