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www.fdanews.com/articles/176893-fda-approves-roches-egfr-mutation-test
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FDA Approves Roche’s EGFR Mutation Test

June 2, 2016

The FDA has greenlighted Roche’s liquid biopsy Cobas EGFR Mutation Test v2 for the detection of the epidermal growth factor receptor gene linked to non-small cell lung cancer.

The companion diagnostic test is the first FDA-approved one designed to pinpoint the EGFR gene in DNA from plasma or tumor tissue. The test is a companion diagnostic for cancer drug Tarceva. — Anisa Jibrell

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