The FDA on June 1, 2016 approved cobas EGFR Mutation Test v2, using plasma specimens, as a companion diagnostic test for the detection of exon 19 deletions or exon 21 (L858R) substitution mutations in the Epidermal Growth Factor Receptor (EGFR) gene, to identify patients with metastatic Non Small Cell Lung Cancer (NSCLC) eligible for treatment with TARCEVA® (Erlotinib). Cobas EGFR Mutation Test v2 is a product of Roche Molecular Systems, Inc.