The cobas EGFR Mutation Test v2 is an FDA approved companion diagnostic for the detection of EGFR mutations in NSCLC
Roche has secured the US Food and Drug Administration (FDA) approval for expanded use of its cobas EGFR Mutation Test v2 as a companion diagnostic (CDx) for non-small cell lung cancer (NSCLC) therapies.
In June 2016, cobas EGFR Mutation Test v2 has been granted the FDA liquid biopsy approval as a CDx for the NSCLC therapy.
The regulatory approval allows the expanded use of test as CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies.
TKI therapies will be deigned to target EGFR mutations L858R and Exon 19 Deletions, in line with the approved therapeutic product labelling.
Also, the test can be used as a CDx for any future approved EGFR TKI therapies targeting the same mutations, eliminating the need for individual clinical studies for each new therapy.
The cobas EGFR Mutation Test v2 detects EGFR gene mutations in NSCLC patients
The cobas EGFR Mutation Test v2 is a real-time polymerase chain reaction (PCR) test designed for the qualitative detection of defined mutations of the EGFR gene in NSCLC patients.
The PCR test will detect the defined EGFR mutations using DNA isolated from formalin-fixed paraffin-embedded tumour tissue (FFPET) or circulating tumour DNA (ctDNA) from the plasma samples.
The Swiss drugmaker said that the test has been clinically validated in various clinical trials as a companion diagnostic (CDx) for both 1st and 2nd line EGFR TKI therapy.
Roche Sequencing Solutions head Neil Gunn said: “Clinicians can now have greater confidence in the robustness, reliability and proven clinical utility of the cobas EGFR Mutation Test v2 when evaluating lung cancer patients who may benefit from targeted EGFR TKI therapies.
“By approving a single test for a broad group of therapies, this new and innovative approach by the FDA can pave the way for future EGFR TKI therapies to utilise the cobas EGFR Mutation Test v2 to help identify patients for personalised medicine.”