Roche has CE Mark for cobas EGFR Mutation Test v2 test to identify mutations in the EGFR gene for NSCLC

Roche has announced the commercial availability in countries that accept the CE mark of the cobas EGFR Mutation Test v2, the first oncology assay from Roche that utilises either plasma or tumour tissue as a sample. The test identifies 42 mutations in the epidermal growth factor receptor (EGFR) gene, the most of any in vitro diagnostic on the market, and can also be used as an aid in selecting eligible patients with non-small cell lung cancer (NSCLC) for therapy with an EGFR tyrosine kinase inhibitor (TKI).

According to a recent survey of more than 550 oncologists, EGFR genetic testing is not being conducted in about 25 percent of patients with NSCLC. Some of the reasons for not testing included lack of diagnostic material and cases where a patient was deemed unfit to undergo biopsy. With the cobas EGFR Mutation Test v2 being validated with both tissue and plasma sample types, patients who previously did not qualify for biopsy now have the opportunity to receive a result from a simple plasma test to guide the corresponding therapy.