Roche’s cobas EGFR Mutation Test v2 approved by Japanese health officials

Health officials in Japan have approved the use of the cobas EGFR Mutation Test v2, developed by Roche.

The test includes expanded mutation coverage of the epidermal growth factor receptor (EGFR) gene in DNA derived from tumour tissue, which is designed to detect sensitising and resistant mutations in non-small cell lung cancer patients.

People with this condition and EGFR mutations are considered suitable for treatments with therapies such as Tarceva (erlotinib), Gilotrif (afatinib), and IRESSA (gefitinib), as well as TAGRISSO.

Uwe Oberlaender, head of Roche Molecular Diagnostics, commented: "The approval in Japan for the cobas® EGFR Mutation Test v2 is a testament to the importance of molecular testing for targeted therapies."

He added that more than half of Asian patients with advanced non-small cell lung cancer have an EGFR mutation.

As a result, he believes knowing the specific mutation can let the clinician know what the best treatment regimen might be and who is eligible for the targeted therapy.