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NEW YORK – Guardant Health said Friday that the US Food and Drug Administration has approved its targeted next-generation sequencing liquid biopsy assay, Guardant360 CDx, for tumor mutation profiling in advanced cancer patients with any solid malignant neoplasm.

The agency also approved a companion diagnostic indication for the test to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor alterations who may benefit from treatment with osimertinib (AstraZeneca's Tagrisso).

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