Switzerland’s Roche has received approval from the US Food and Drug Administration (FDA) for its cobas epidermal growth factor receptor (EGFR) mutation test v2 as a companion diagnostic for non-small cell lung cancer (NSCLC) therapies.


The firm’s next-generation test comprises expanded mutation coverage of EGFR gene in DNA derived from tumor tissue.

The test can be used to select eligible NSCLC patients who hold a T790M mutation, for treatment with AstraZeneca’s newly approved therapy Tagrisso (osimertinib) or for eligible NSCLC patients with exon 19 deletions or L858R mutations for treatment with Tarceva (erlotinib).

Roche Molecular Diagnostics head Paul Brown said: "Today’s FDA approval and companion diagnostic designation for the cobas EGFR Mutation Test v2 is an important advancement in the testing of lung cancer patients.

"With this test, physicians can identify those patients whose tumor harbors an EGFR mutation and therefore are eligible for important targeted therapies for first-line and subsequent lines of treatment, thus expanding their therapy options."

The cobas EGFR mutation test v2 was developed based on the cobas EGFR mutation test, which is already available in the US. It is an 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 amplification and detection coupled with software that automates results interpretation and reporting.

According to Roche, the cobas 4800 system menu for oncology in the US comprises cobas EGFR mutation test v2, cobas EGFR mutation test, the cobas KRAS mutation test, and cobas BRAF V600 mutation test.

In August this year, Roche agreed to acquire US-based in vitro diagnostics firm GeneWEAVE BioSciences for around $425m.

Image: The administration and R&D buildings, Roche Diagnostics, Rotkreuz. Photo: courtesy of F. Hoffmann-La Roche Ltd.