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FDA approves cobas EGFR Mutation Test for use with Iressa in lung cancer
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The FDA expanded the approval of the cobas EGFR Mutation Test v2 as a companion diagnostic with gefitinib in the first-line treatment of patients with non-small cell lung cancer.
The cobas test (Roche) is indicated for the detection of 42 mutations of the EGFR gene to identify patients who may benefit from EGFR tyrosine kinase inhibitor therapies, including erlotinib (Tarceva; Genentech, Astellas Oncology), osimertinib (Tagrisso, AstraZeneca) and, now, gefitinib (Iressa, AstraZeneca).
“The cobas EGFR Mutation Test v2 is a companion diagnostic test that supports Iressa as an additional therapeutic option for patients and gives physicians greater flexibility to make appropriate treatment decisions” Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a company-issued press release. “Additionally, the ability to provide reliable patient test results in less than 1 day from sample preparation to report, eliminates delays and provides patients with the ability to begin therapy regimens earlier.”
The test detects EGFR mutations via liquid biopsy or tumor tissue biopsy and is the only FDA-approved test for NSCLC that uses both plasma and tissue.