FDA grants Roche label extension for the cobas EGFR Mutation Test v2 for use with plasma as a companion diagnostic for TAGRISSO


Test utilizes either plasma or tumor tissue, as a companion diagnostic for non-small cell lung cancer therapies

Roche (SIX: RO, ROG; OTCQX, RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension of the cobas® EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s non-small cell lung cancer (NSCLC) therapy TAGRISSO™ (osimertinib).


The label extension for the cobas® EGFR Mutation Test v2 to include another TKI (tyrosine-kinase inhibitor) therapy shows our continued commitment to helping healthcare providers make the best diagnosis for their NSCLC patients at multiple stages of their treatment pathway,

said Uwe Oberlaender, Head of Roche Molecular Diagnostics.


On June 1st, 2016, the FDA granted approval of the cobas® EGFR Mutation Test v2, making it the first FDA-approved liquid biopsy test for use in clinical decisions. The test is the only companion diagnostic that is FDA-approved for the detection of the epidermal growth factor receptor (EGFR) gene in DNA derived from plasma or tumor tissue. NSCLC patients who have EGFR exon 19 deletions or L858R mutations are candidates for the EGFR-targeted therapy Tarceva® (erlotinib), in first-line treatment, and patients who have the resistance mutation T790M are candidates for TAGRISSO™ in subsequent lines of treatment. Current clinical guidelines, including those from 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 based upon 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 polymerase chain reaction (PCR) 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® KRAS Mutation Test, and the cobas® 4800 BRAF V600 Mutation Test.




TAGRISSO™ (osimertinib) 80mg once-daily tablet is the first medicine indicated for the treatment of metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy.


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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.