Plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer

The 7 technologies described in this briefing are plasma epidermal growth factor receptor (EGFR) mutation tests. They are used to inform the decision to offer EGFR tyrosine kinase inhibitors (EGFR‑TKIs) for treating locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults.

The innovative aspects are that the tests measure circulating tumour DNA (ctDNA) in a blood sample rather than the standard histopathological assessment of a tumour biopsy.

The intended place in therapy would be as an alternative to tissue EGFR testing or before tumour testing to inform decisions about prescribing EGFR‑TKIs. Plasma testing may be particularly useful for people whose disease has developed resistance to an EGFR‑TKI and who could be offered second-line EGFR‑TKIs, if appropriate, without having further tissue testing.

The main points from the evidence summarised in this briefing are from 7 non-UK-based prospective studies with 2,106 adults. They show that the diagnostic accuracy of plasma EGFR mutation testing has a similar specificity, but lower sensitivity, compared with tissue EGFR mutation testing in adults with locally advanced or metastatic NSCLC.

Key uncertainties around the evidence or technology are that tests for identifying EGFR‑TK mutations are rapidly evolving and there is no established gold-standard test against which to evaluate them.

The cost of plasma EGFR mutation tests range from £138.05 to £230.22 per unit (excluding VAT). The resource impact is similar to that of standard care but plasma EGFR mutation testing could be cost saving if it led to fewer tissue biopsies.