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FDA Approves Roche Cobas EGFR Mutation Test as CDx with AstraZeneca's Tagrisso Drug

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Roche's Cobas EGFR Mutation Test v2 as a companion diagnostic alongside AstraZeneca's Tagrisso (osimertinib) for non-small cell lung cancer patients, Roche said today.

The test, which runs on the Cobas 4800 qPCR system, looks for mutations in the epidermal growth factor receptor (EGFR) gene in DNA derived from tumor tissue and is used to identify NSCLC patients for whom treatment with Tarceva (erlotinib) in first-line therapy and Tagrisso in second and subsequent lines of therapy may be effective. It has expanded mutation coverage compared to the first version of the test.

NSCLC patients who harbor a T790M mutation are eligible for treatment with Tagrisso, while patients with exon 19 deletions or L858R mutations may benefit from Tarceva.

"Now that Tagrisso is approved, ensuring that patients who progress on an EGFR tyrosine kinase inhibitor (TKI) are tested for the T790M [mutation] is critical to identifying those that are most likely to benefit from this new medicine," Antoine Yver, head of oncology for global medicines development at AstraZeneca, said in a statement.

Besides the EGFR Mutation Test and EGFR Mutation Test v2, Roche offers two other oncology tests on the Cobas 4800 in the US, the KRAS Mutation Test and the BRAF V600 Mutation Test.

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