Guidance

1 Recommendations

1 Recommendations

1.1 The tests and test strategies listed below are recommended as options for detecting epidermal growth factor receptor tyrosine kinase (EGFR‑TK) mutations in the tumours of adults with previously untreated, locally advanced or metastatic non-small-cell lung cancer (NSCLC), when used in accredited laboratories participating in an external quality assurance scheme. The laboratory-developed tests should be designed to detect the mutations that can be detected by one of the CE‑marked tests as a minimum.

  • therascreen EGFR RGQ PCR Kit (CE‑marked, Qiagen)

  • cobas EGFR Mutation Test (CE‑marked, Roche Molecular Systems)

  • Sanger sequencing of samples with more than 30% tumour cells and therascreen EGFR RGQ PCR Kit for samples with lower tumour cell contents

  • Sanger sequencing of samples with more than 30% tumour cells and cobas EGFR Mutation Test for samples with lower tumour cell contents

  • Sanger sequencing followed by fragment length analysis and polymerase chain reaction (PCR) of negative samples.

1.2 There was insufficient evidence for the Committee to make recommendations on the following methods:

  • high-resolution melt analysis

  • pyrosequencing combined with fragment length analysis

  • single-strand conformation polymorphism analysis

  • next-generation sequencing

  • therascreen EGFR Pyro Kit (CE‑marked, Qiagen).