The significance of tissue-agnostic biomarkers in solid tumors: the more the merrier?

Valerio GristinaPasquale PisapiaNadia BarracoFrancesco PepeFederica IaconoMaria La MantiaMarta PeriAntonio GalvanoLorena IncorvaiaGiuseppe BadalamentiViviana BazanGiancarlo TronconeAntonio RussoUmberto Malapelle

Published in: Expert review of molecular diagnostics (2023)

To strengthen the framework for tissue-agnostic approvals, the dialogue between regulatory, industrial, and academic parties should be intensified. Critical questions include the development of an efficient network system that can overcome the heterogeneity of patients' inclusion criteria along with the increasingly difficult interpretation of next-generation sequencing (NGS) profiling technologies. Cost-effectiveness and risk-benefit studies are needed in the national context considering the modalities of access to diagnostic tests and reimbursement of treatments.

Keyphrases

end stage renal disease
ejection fraction
newly diagnosed
single cell
prognostic factors
heavy metals
transcription factor
gene expression
quality improvement
copy number
circulating tumor
patient reported