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FDA approves FoundationOne Liquid CDx for a group of TKIs

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Dec. 28, 2022—The FDA has approved Foundation Medicine‘s FoundationOne Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of tyrosine kinase inhibitors approved by the FDA for this indication. The therapies for which this test is approved are Tarceva (erlotinib), Tagrisso (osimertinib), and Iressa (gefitinib). Moving forward, the company says, FoundationOne Liquid CDx will automatically become a companion diagnostic for future TKIs within this group for NSCLC that are approved by the FDA.

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