[News] Biomarker tests for targeted oncology therapies pose tricky regulatory challenges

The US Food and Drug Administration (FDA) recently announced the launch of a year-long pilot programme regarding diagnostic methods within oncology to address concerns about laboratory-developed tests (LDTs). Molecular and next-generation sequencing profiling tests are often developed and produced within an individual laboratory to select patients for approved therapies tailored to the genetic profile of their tumour. These diagnostic LDTs are innovative and unique to that laboratory, and are often the only means by which rapidly developing biomarker-targeted oncology therapies can be matched to the patients who can benefit.