Roche receives approval in Japan for the cobas EGFR Mutation Test v2


New test includes expanded mutation coverage to detect EGFR mutations in non-small cell lung cancer patients

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved the cobas® EGFR Mutation Test v2 for diagnostic use. The test from Roche includes expanded mutation coverage of the epidermal growth factor receptor (EGFR) gene in DNA derived from tumour tissue, designed to detect both sensitising and resistant mutations in non-small cell lung cancer (NSCLC) patients. NSCLC patients who harbor an EGFR mutation are candidates for EGFR-targeted therapies such as Tarceva® (erlotinib), Gilotrif® (afatinib), and IRESSA® (gefitinib) in first-line treatment, and TAGRISSO™ (osimertinib) in subsequent lines of treatment.


The approval in Japan for the cobas® EGFR Mutation Test v2 is a testament to the importance of molecular testing for targeted therapies,

said Uwe Oberlaender, Head of Roche Molecular Diagnostics.

With more than half of Asian patients with advanced NSCLC having an EGFR mutation, knowing the specific mutation can inform the clinician about what treatment regimen to prescribe and, more importantly, who is eligible for the targeted therapy.


A recent study published in the Journal of Thoracic Oncology found that 51.4 percent of Asian patients with NSCLC have EGFR mutations. Current clinical guidelines, including the National Comprehensive Cancer Network (NCCN) in the U.S., and the European Society for Medical Oncology (ESMO), recommend EGFR mutation testing in patients with advanced NSCLC, prior to administering targeted therapies.


About the cobas® EGFR Mutation Test v2


The cobas® EGFR Mutation Test v2 is built upon the success of the cobas® EGFR Mutation Test available globally today, with expanded mutation coverage that identifies 42 EGFR mutations in exons 18-21, including L858R, exon 19 deletions, and T790M. The test is performed on the cobas® 4800 System, which offers high-performance amplification and detection coupled with software that automates results interpretation and reporting. The cobas® 4800 System menu for diagnostic use in oncology includes the cobas® EGFR Mutation Test v2, the cobas® EGFR Mutation Test, the cobas® KRAS Mutation Test, and the cobas® BRAF V600 Mutation Test.


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cobas EGFR product box

cobas® EGFR Mutation Test v2

The cobas® EGFR Mutation Test v2 is a real-time PCR test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene, including the T790M resistant mutation.