NICE recommends Test for patients with Lung Cancer

Roche announces that the National Institute for Health and Care Excellence (NICE) has issued its Final Guidance recommending use of the CE-marked cobas® EGFR Mutation Test within the NHS for testing tumours in adults with previously untreated, locally advanced or metastatic non-small-cell lung cancer (NSCLC) to inform first-line decisions.

NSCLC accounts for 72% of all lung cancer cases in England and Wales with the estimated proportion of EGFR-TK mutations in NSCLC being 16.6%. Currently there are many different types of tests for EGFR-TK mutations used in NHS laboratories across England. The aim of the NICE technology appraisal was to identify the most clinically and cost-effective tests that should be used to inform first-line treatment decisions. The cobas EGFR Mutation Test is one of only two CE-marked in vitro diagnostic (IVD) tests approved by NICE in this lung cancer disease area.

Dr Andrew Wallace, Consultant Clinical Scientist, commented: “Using assays such as Roche’s cobas EGFR Mutation Test allows clinical laboratories to accurately identify EGFR-TK mutations in clinical samples, which means patients can benefit from the most effective treatment option, either EGFR-TK inhibitors or standard chemotherapy.”

The NICE committee concluded that the difference in the total cost of all the tests was small although the CE-marked EGFR assays were found to be easier to use in certain clinical settings. The laboratory developed Sanger sequencing tests, can only be used in specific circumstances, for example, where there is more than 30% of tumour cells present within the biopsy.

“Roche is committed to continual innovation and improvements in healthcare technology,” said Brigitte Fernandes-McAlear, Director, Roche Molecular Systems, UK.  “The cobas EGFR Mutation Test is an essential part of our personalised healthcare portfolio, enabling effective options for clinicians that ultimately improve patient outcomes.”