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Foundation Medicine gets approval for cancer test in US

December 1, 2017

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Molecular information firm Foundation Medicine has secured approval from the US Food and Drug Administration (FDA) for its comprehensive companion diagnostic test, FoundationOne CDx, for solid tumours.

The genomic profiling (CGP) test is designed to identify people who could benefit from 17 select FDA-approved targeted treatments and to aid physicians in detecting potential candidates for clinical trials.

With genomic biomarkers such as microsatellite instability (MSI) and tumour mutational burden (TMB), the test would also predict the use of additional targeted oncology therapies.

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