Posted by Michael Wonder on 04 Jul 2023
Biomarker tests for targeted oncology therapies pose tricky regulatory challenges
29 June 2023 - The US FDA recently announced the launch of a year-long pilot programme regarding diagnostic methods within oncology to address concerns about laboratory-developed tests.
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.
