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

Regulatory information

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued 1 manufacturer field safety notice for the Cobas epidermal growth factor receptor (EGFR) mutation test v2 (Roche) from April 2016. It reported that several mutation-positive samples generated "no mutation detected" results (false negatives) in internal studies. As a result of these findings, the instructions were revised and no further safety issues have been reported since. No other field safety notices or medical device alerts were identified for the other technologies in this briefing.

The technologies included in this briefing have received regulatory approval under the European Union 98/79/EC in vitro diagnostics (IVD) directive.