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Foundation Medicine's FoundationOne CDx Receives the US FDA's Approval as a CDx for Vitrakvi (larotrectinib)

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Foundation Medicine's FoundationOne CDx Receives the US FDA's Approval as a CDx for Vitrakvi (larotrectinib)

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  • The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. The genomic test is currently approved as a CDx for 20+ therapies
  • The FoundationOne CDx is the tissue-based CGP test approved to detect NTRK1/2/3 fusions across all solid tumor types and identify patients who may be appropriate for treatment with Vitrakvi
  • The approval of Vitrakvi was based on three studies including LOXO-TRK-14001-  SCOUT- and NAVIGATE studies and is indicated for the treatment of adult and pediatric patients with solid tumors that have NTRK gene fusion without a known acquired resistance mutation- are metastatic or where surgical resection is likely to result in severe morbidity- and have no satisfactory alternative treatments or that have progressed following treatment

­ Ref: Businesswire | Image: Clinical OMICs

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