NICE

DG9 EGFR‑TK mutation testing in adults with locally advanced or metastatic non-small-cell lung cancer

The project evaluated commercial assays for detecting EGFR mutation in patients with non-small cell lung cancer. The original guidance recommended:

  • 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.

However, there was insufficient evidence to recommend:

  • 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)