FDA approval allows the use of cobas EGFR Mutation Test v2 as a companion diagnostic for a group of EGFR TKI therapies
(PRNewsfoto/Roche)
Roche has received the US Food and Drug Administration (FDA) approval for the expanded use of its cobas EGFR Mutation Test v2, as a companion diagnostic (CDx) for non-small cell lung cancer (NSCLC) therapies.
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.
The regulatory approval allows the expanded use of the test as CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies that target EGFR mutations L858R and Exon 19 Deletions.
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 CDx for both 1st and 2nd line EGFR TKI therapy.
In June 2016, cobas EGFR Mutation Test v2 has been granted the FDA liquid biopsy approval as a CDx for the NSCLC 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.”