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FDA Expands Approval of Roche Cobas Test as CDx for EGFR Deletions, Mutations

NEW YORK (GenomeWeb) – Roche said today that the US Food and Drug Administration has granted premarket approval for expanded use of its Cobas EGFR Mutation Test v2 as a companion diagnostic test with AstraZeneca's Tagrisso (osimertinib) for non-small cell lung cancer patients.

The agency has approved the CDx for first-line treatment of patients diagnosed with metastatic NSCLC whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations. It had previously approved the test as a CDx with Tagrisso for second-line treatment and beyond in NSCLC patients who test positive for the EGFR T790M mutation.

The test is also approved as a CDx with Tarceva (erlotinib) for NSCLC patients who test positive for the EGFR exon 19 deletion or L858R sensitizing mutations.

Approvals thus far cover tissue and blood plasma patient biopsies, Roche said.

EGFR testing in plasma offers a non-invasive option for patients using a blood draw for those who are not eligible for a tissue biopsy, and the Cobas test workflow enables patients and clinicians to obtain results in one day, the firm said.

That provides the information needed "to choose the optimal therapy and avoid delays in getting…patients started on treatment," Sid Scudder, senior director of clinical research, genomics, and oncology at Roche Molecular Diagnostics, said in a statement.

Roche said clinical studies have demonstrated that patients benefit from tyrosine kinase inhibitor therapies after they have been diagnosed with NSCLC and have tested positive for defined mutations of the EGFR gene.