- New indication approval for cobas EGFR Mutation Test v2 as companion diagnostic, follows previous approvals with Tarceva (erlotinib) and TAGRISSO (osimertinib)
- Results for EGFR mutations can be available in less than one day with the cobas EGFR Mutation Test v2 to determine if patients can benefit from IRESSA
- Approval for use of either tumour tissue or plasma biopsy provides patients and clinicians a non-invasive sample collection option
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval from the U.S. Food and Drug Administration (FDA) for the cobas® EGFR Mutation Test v2 as a companion diagnostic test (CDx) with IRESSA®. A CDx 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 (TKI) therapies.
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,
said Uwe Oberlaender, Head of Roche Molecular Diagnostics.
Additionally, the ability to provide reliable patient test results in less than one day from sample preparation to report, eliminates delays and provides patients with the ability to begin therapy regimens earlier.
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 non-invasive option for patients using a simple blood draw for those who are not eligible for a tissue biopsy.