FDA approves cobas EGFR Mutation Test v2 for non-small cell lung cancer therapies- Roche
Roche has received FDA approval for cobas EGFR Mutation Test v2 as a companion diagnostic for non-small cell lung cancer therapies. The next-generation test from Roche includes expanded mutation coverage of the epidermal growth factor receptor (EGFR) gene in DNA derived from tumour tissue. The test can be used to select eligible non-small cell lung cancer (NSCLC) patients who harbour a T790M mutation, for treatment with AstraZeneca's newly approved therapy, Tagrisso (osimertinib), or for eligible NSCLC patients with exon 19 deletions or L858R mutations for treatment with Tarceva (erlotinib).
The cobas EGFR Mutation Test v2 is built upon the success of the cobas EGFR Mutation Test available in the US market, with expanded mutation coverage that identifies 42 EGFR mutations in exons 18–21, including L858R, exon 19 deletions, and T790M. The test is performed on the cobas 4800 System, which offers high-performance amplification and detection coupled with software that automates result interpretation and reporting.