Abstract

Cancers are diseases of DNA dis-function and new diagnostic classification systems based on somatic genomic alterations are rapidly replacing traditional systems based on primary site and histology. A large proportion of the cancer drugs that have been approved by regulatory authorities in the past decade have an intended use for a restricted subset of patients. The intended use subset is often characterised by genomic de-regulation of a gene related to the molecular target of the drug. Much current drug development in oncology involves co-development of a companion in-vitro diagnostic test for selecting the subset of patients who are likely to benefit from the drug. The companion diagnostics are often based on DNA sequencing of patients’ tumours.