Standards in molecular diagnostics for the discovery and validation of clinically useful cancer biomarkers.
Journal: Expert Rev Mol Diagn
Date: 2013 Jun
Major Program(s) or Research Group(s): CBRG
PubMed ID: 23782249
PMC ID: not available
Abstract: Recent discoveries in cancer biology have greatly increased the understanding of cancer at the molecular level, but translating this knowledge into clinically useful diagnostic tests has proved challenging. More efficient transfer of new molecular tests into patient care requires better standardization of laboratory practices, measurement methods and data management. The workshop assembled experts from National Cancer Institute, US FDA, National Institute of Standards and Technology, academia and industry, to address the most efficient approaches to biomarker standardization and validation. The workshop participants described the current state of research in molecular diagnostics standardization and addressed three questions: what has worked? What has not?And what needs improving?