English 
Italian CASI CLINICI – Case Reports
Volume:
Biochimica Clinica 2014; 38(5) 378-388
Pubblicato on-line:
DOI:
Il lungo viaggio dei marcatori di neoplasia dalla ricerca alla clinica
AUTORI
1Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, Canada
2Department of Laboratory Medicine and Pathobiology, University of Toronto, Canada
3Department of Clinical Biochemistry, University Health Network, Toronto, Canada
Traduzione a cura di Giovanni Palladini e Giampaolo Merlini
ABSTRACT
The long journey of cancer biomarkers from the bench to the clinic
Protein cancer biomarkers serve multiple clinical purposes, both early and late, during disease progression. The search for new and better biomarkers has become an integral component of contemporary cancer research. However, the number of new biomarkers cleared by the US Food and Drug Administration has declined substantially over the last 10 years, raising concerns regarding the efficiency of the biomarker-development pipeline. We describe different clinical uses of cancer biomarkers and their performance requirements. We also present examples of protein cancer biomarkers currently in clinical use and their limitations. The major barriers that candidate biomarkers need to overcome to reach the clinic are addressed. Finally, the long and arduous journey of a protein cancer biomarker from the bench to the clinic is outlined with an example. The journey of a protein biomarker from the bench to the clinic is long and challenging. Every step needs to be meticulously planned and executed to succeed. The history of clinically useful biomarkers suggests that at least a decade is required for the transition of a marker from the bench to the bedside. Therefore, it may be too early to expect that the new technological advances will catalyze the anticipated biomarker revolution any time soon.