Shots:

• 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

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