Roche has received liquid biopsy approval from the US Food and Drug Administration (FDA) for cobas EGFR mutation test v2 for use with plasma samples, as a companion diagnostic for the non-small cell lung cancer (NSCLC) therapy.
It is claimed to be the only companion diagnostic that secured FDA approval to detect epidermal growth factor receptor (EGFR) gene in DNA derived from plasma or tumor tissue.
Roche said NSCLC patients who have EGFR exon 19 deletions or L858R mutations are candidates for the EGFR-targeted therapy Tarceva in first-line treatment.
Roche molecular diagnostics head Uwe Oberlaender said: "The FDA approval of the cobas EGFR Mutation Test v2 for liquid biopsy for diagnostic use sets a standard in testing for NSCLC patients.
"The approval of the test for use with plasma samples means patients who previously could not be tested now have a testing option for personalized healthcare."
Roche has developed the new test based on the success of cobas EGFR mutation test. It has expanded mutation coverage that identifies 42 EGFR mutations in exons 18-21, including L858R, exon 19 deletions, and T790M.
The test will be carried out on the cobas 4800 system, which provides polymerase chain reaction (PCR) amplification and detection coupled with software that automates results interpretation and reporting.
The company also produces cobas KRAS mutation test and the cobas 4800 BRAF V600 mutation test.
Astellas Pharma US, along with Genentech, developed and commercialized Tarceva in the US. It is commercialized by Chugai in Japan and Roche in other parts of the world.
Roche also produces cobas KRAS mutation test and the cobas 4800 BRAF V600 mutation test.