Standards in molecular diagnostics for the discovery and validation of clinically useful cancer biomarkers.

Author(s): Vydelingum NA,  Sorbara L,  Wagner P,  Srivastava S

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?