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FDA Approves cobas EGFR Mutation Test v2 as Companion Diagnostic With Gefitinib in First-Line Treatment of NSCLC

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The U.S. Food and Drug Administration (FDA) recently approved the cobas EGFR Mutation Test v2 as a companion diagnostic test with gefitinib (Iressa) for the first-line treatment of patients with non–small cell lung cancer (NSCLC). A companion diagnostic test provides information that is essential for the safe and effective use of a corresponding therapeutic product. Clinical studies have demonstrated that patients diagnosed with NSCLC who test positive for defined mutations of the epidermal growth factor receptor (EGFR) gene benefit from tyrosine kinase inhibitor therapies.

The cobas EGFR Mutation Test v2 is currently the only FDA-approved diagnostic test for NSCLC using liquid biopsy. EGFR testing in plasma offers a noninvasive option for patients, using a simple blood draw for those who are not eligible for a tissue biopsy.

More About the cobas EGFR Mutation Test v2

The cobas EGFR Mutation Test v2 is a real-time polymerase chain reaction (PCR) test for the qualitative detection of 42 defined mutations of the EGFR gene in exons 18–21, including L858R, exon 19 deletions, and T790M mutations. This in vitrodiagnostic test is the first and currently the only FDA-approved EGFR test to include both tissue and liquid biopsy as patient sample types for testing. A number of published clinical studies, such as AURA, AURA2, FLAURA, ENSURE, EURTAC, and FASTACT2, have demonstrated that the cobas  EGFR Mutation Test v2 detects defined mutations of the EGFR gene from a tumor tissue biopsy or from plasma and is able to identify those patients most likely to respond to EGFR tyrosine kinase inhibitor therapies. The test is performed on the cobas 4800 System, which offers high-performance PCR amplification and detection coupled with software that automates result interpretation and reporting.

About Gefitinib

Gefitinib is a targeted monotherapy for the treatment of patients with advanced or metastatic EGFR exon 19 deletions or exon 21 (L858R) substitution mutation–positive NSCLC. Gefitinib acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus inhibiting the transmission of signals involved in the growth and spread of tumors.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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