Pleasanton, 23 August, 2018
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.
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-vitro diagnostic (IVD) test is the first and currently the only FDA-approved EGFR test to include both tissue and liquid biopsy (plasma) as patient sample types for testing. A number of well-published clinical studies such as AURA, AURA2, FLAURA, ENSURE, EURTAC, and FASTACT2, have now demonstrated that the cobas® EGFR Mutation Test v2 is a robust and reliable diagnostic test for the detection of defined mutations of the EGFR gene from a tumour tissue biopsy or from plasma and is able to identify those patients most likely to respond to EGFR tyrosine kinase inhibitor (TKI) 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.
IRESSA® (gefitinib) is a targeted monotherapy for the treatment of patients with advanced or metastatic epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutation-positive NSCLC. IRESSA® acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus inhibiting the transmission of signals involved in the growth and spread of tumors.
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