DOCUMENTI - Documents
Biochimica Clinica 2012; 36(1) 40-45
Guida all’uso clinico dei biomarcatori in oncologia: le prospettive
1Centro Regionale Biomarcatori, U.O. Laboratorio Analisi, Dipartimento di Patologia Clinica, Azienda ULSS 12 Veneziana,
2Fondazione ABO, Venezia
3GRADE Working Group, Cochrane Methodology Review Group, Castelvetro di Modena, MO
Guidelines for clinical use of biomarkers in oncology: an outlook
Although much information has recently been accumulated in the field of biomarkers, no new markers have been approved by the U.S. Food and Drug Administration for clinical use over the last two decades. This fact emphasizes the need to strengthen translational research in order to select, evaluate, and validate the most promising biomarkers in a reliable and efficient manner. The most innovative development regarding traditional markers is in their dynamic assessment in the diagnostic scenario. This approach is under evaluation for several biomarkers, e.g. PSA for prostate cancer and CA 125 for ovarian cancer. On the other hand, new biomarkers are under study. Some promising biomarkers, such as the antibody immune response indicators, mechanism and/or microenvironment associated markers, and circulating tumour cells, are already in the validation phase. Even if they have preliminarily demonstrated very high potential, there is however insufficient evidence to support their definitive clinical use.