Posted by Michael Wonder on 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
29 October 2020 - The new FDA approval allows the test to be used as a companion diagnostic for a broad group of EGFR TKI therapies.
Roche today announced U.S. FDA approval of expanded claims for the cobas EGFR Mutation Test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of non-small cell lung cancer.
This claim expansion allows the test to be used as a CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordance with the approved therapeutic product labelling. The group claim will also enable the test to be used as a CDx for any future approved EGFR TKI therapies targeting the same mutations, without the need to conduct individual clinical studies with the test for each new therapy.
