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Companion Diagnostics

Diagnostic tests co-developed with therapeutics to identify patients most likely to benefit from a specific treatment. Essential for precision medicine and increasingly required by regulators for targeted therapy approvals.

Key Companies

Roche DiagnosticsAgilent/DakoGuardant HealthThermo Fisher

Recent Signals

REGULATORY

FDA Approves Guardant360 as Companion Diagnostic for BRAF-Mutant CRC

Guardant Health's liquid biopsy test wins CDx approval for encorafenib in BRAF V600E-mutant metastatic colorectal cancer, expanding the utility of blood-based genomic profiling across cancer types.

Apr 13, 2026 · 4 min read