NICE recommends Roche assay for detecting lung cancer

Final Guidance supports use of cobas EGFR Mutation Test among adults with previously untreated, locally-advanced or metastatic non-small-cell lung cancer

cobas EGFR Mutation Test

The National Institute for Health and Care Excellence (NICE) has recommended the CE-marked cobas EGFR Mutation Test for use on patients with lung cancer.

A Final Guidance document has been issued supporting use of the Roche assay among adults with previously untreated, locally-advanced or metastatic non-small-cell lung cancer (NSCLC) in order 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.

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 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 at Central Manchester University Hospitals NHS Foundation Trust, said: “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, such as when there is limited molecular diagnostics technical support. The laboratory-developed Sanger sequencing tests, however, 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 of Roche Molecular Systems in the 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.”

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