FDA approves Roche’s new test as companion diagnostic for NSCLC therapies

15 November 2015 (Last Updated November 15th, 2015 18:30)

The US Food and Drug Administration (FDA) has approved Roche's cobas epidermal growth factor receptor (EGFR) mutation test v2 as a companion diagnostic for non-small cell lung cancer (NSCLC) therapies.

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The US Food and Drug Administration (FDA) has approved Roche's cobas epidermal growth factor receptor (EGFR) mutation test v2 as a companion diagnostic for non-small cell lung cancer (NSCLC) therapies.

The test features expanded mutation coverage of the EGFR gene in DNA derived from tumor tissue. It can be used to select eligible NSCLC patients who have a T790M mutation to treat with AstraZeneca's Tagrisso (osimertinib) lung cancer therapy.

It can also be used for eligible NSCLC patients with exon 19 deletions or L858R mutations for treatment with Tarceva (erlotinib), a once-daily, oral non-chemotherapy medicine for advanced or metastatic NSCLC.

"The test features expanded mutation coverage of the EGFR gene in DNA derived from tumor tissue."

Roche developed the cobas EGFR mutation test v2 based on the cobas EGFR mutation test, which is available in the US.

It finds 42 EGFR mutations in exons 18-21, including L858R, exon 19 deletions, and T790M.

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."

Roche said the cobas EGFR mutation test v2 is aimed to be used as an aid in finding NSCLC patients for whom treatment with Tarceva in first-line therapy, and Tagrisso in second and successive lines of therapy, may be effective.


Image: cobas IMPACT, a chip-based immunological multimarker assay (biomarkers). Photo: courtesy of F Hoffmann-La Roche.