Roche’s diagnostic test for NSCLCOctober 10, 2018
The US FDA has approved Roche’s cobas EGFR Mutation Test v2 as a companion diagnostic test (CDx) with gefitinib (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 tumours.
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 EGFR gene benefit from tyrosine kinase inhibitor (TKI) 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 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.
Clinical studies such as AURA, AURA2, FLAURA, ENSURE, EURTAC, and FASTACT2, have demonstrated the reliability of the cobas EGFR Mutation Test v2, Roche said.Non-surgical option for